Company · US
Cook, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2024. Name variants (Inc, Corp, punctuation) are merged.
365510(k) clearances (0 in 12 months)
650recalls (25 in 12 months)
381recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 136 |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 121 |
| DQO | Catheter, Intravascular, Diagnostic | 100 |
| DQX | Wire, Guide, Catheter | 87 |
| DYB | Introducer, Catheter | 87 |
| DQY | Catheter, Percutaneous | 35 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 35 |
| JOH | Tube Tracheostomy And Tube Cuff | 29 |
| FAD | Stent, Ureteral | 21 |
| KRA | Catheter, Continuous Flush | 20 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 19 |
| KRD | Device, Vascular, For Promoting Embolization | 18 |
| LJE | Catheter, Nephrostomy | 14 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 13 |
| MQF | Catheter, Assisted Reproduction | 12 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 10 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 9 |
| GEX | Powered Laser Surgical Instrument | 8 |
| LQR | Dislodger, Stone, Biliary | 8 |
| BWC | Needle, Emergency Airway | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 8, 2024 | K233177 | Nest VT Vitrification Device Cook Incorporated | MQK |
| May 16, 2023 | K222254 | Gunther Tulip Vena Cava Filter Retrieval Set Cook Incorporated | MMX |
| Oct 28, 2022 | K223098 | Bakri Essential Postpartum Balloon Cook Incorporated | OQY |
| Apr 6, 2021 | K210734 | Endovascular Dilator and Sets Cook Incorporated | DRE |
| Feb 16, 2021 | K203670 | Extra Large Check-Flo Introducer Cook Incorporated | DYB |
| Jan 29, 2020 | K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc Cook Incorporated | LJE |
| Dec 16, 2019 | K190903 | Lawson Retrograde Nephrostomy Wire Puncture Set Cook Incorporated | LJE |
| Dec 12, 2019 | K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer T Cook Incorporated | JOH |
| Dec 12, 2019 | K191163 | Lumax Guiding Catheter Cook Incorporated | DQY |
| Oct 11, 2019 | K190084 | McLean-Ring Enteral Feeding Tube Set Cook Incorporated | KNT |
| Aug 5, 2019 | K183323 | UPJ Occlusion Balloon Catheter Cook Incorporated | EYB |
| Jul 22, 2019 | K182985 | Roadrunner PC Wire Guide, Olcott Torque Device Cook Incorporated | DQX |
| Jul 16, 2019 | K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set Cook Incorporated | LJE |
| Jun 26, 2019 | K191485 | Deflectable Brush Biopsy Set Cook Incorporated | FDX |
| Jun 26, 2019 | K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set Cook Incorporated | KGC |
| Jun 17, 2019 | K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter Cook Incorporated | EYB |
| May 29, 2019 | K182403 | Peel-Away Introducer Cook Incorporated | FED |
| May 17, 2019 | K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Tran Cook Incorporated | MQF |
| May 17, 2019 | K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle Cook Incorporated | LJE |
| May 17, 2019 | K182252 | Cook Unimpregnated Central Venous Catheter Cook Incorporated | FOZ |
| May 1, 2019 | K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy Set Cook Incorporated | FDX |
| Apr 25, 2019 | K182071 | Multi-Sideport Catheter Infusion Set Cook Incorporated | KRA |
| Apr 23, 2019 | K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set Cook Incorporated | FAD |
| Apr 4, 2019 | K182399 | Park Blade Septostomy Catheter Cook Incorporated | DXF |
| Mar 29, 2019 | K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter Cook Incorporated | LKF |
| Mar 27, 2019 | K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set Cook Incorporated | LJE |
| Mar 22, 2019 | K181722 | Polyethylene Catheter Cook Incorporated | DQO |
| Feb 15, 2019 | K181353 | Lunderquist® Fixed Core Wire Guide Cook Incorporated | DQX |
| Jan 18, 2019 | K181097 | Cook Cystostomy Catheter Set Cook Incorporated | KOB |
| Jan 11, 2019 | K183467 | Roadrunner Extra Support Wire Guide Cook Incorporated | DQX |
| Dec 26, 2018 | K182709 | One-Step Suprapubic Introducer Cook Incorporated | KOB |
| Dec 20, 2018 | K183036 | Dilator Sets Cook Incorporated | DRE |
| Dec 20, 2018 | K180830 | Reuter Tip Deflecting Wire Guide Cook Incorporated | DQX |
| Dec 19, 2018 | K180846 | Arterial Pressure Monitoring Set/Tray Cook Incorporated | DQO |
| Dec 12, 2018 | DEN170055 | Retrograde Intubation Set Cook Incorporated | QCX |
| Nov 30, 2018 | K180792 | Arterial Pressure Monitoring Set/Tray Cook Incorporated | DQO |
| Nov 23, 2018 | K180557 | Greene Renal Transplant Stent Set Cook Incorporated | FAD |
| Nov 6, 2018 | K181757 | Günther Tulip® Vena Cava Filter Retrieval Set Cook Incorporated | MMX |
| Oct 30, 2018 | K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set Cook Incorporated | KOB |
| Oct 26, 2018 | K180300 | Margolin HSG Cannula, Goldstein Sonohysterography Catheter Cook Incorporated | LKF |
| Oct 26, 2018 | K180291 | Cook Silicone Balloon HSG Catheter Cook Incorporated | LKF |
| Oct 26, 2018 | K180286 | Polyethylene Catheter Cook Incorporated | DQO |
| Oct 24, 2018 | K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia Cook Incorporated | MQF |
| Oct 5, 2018 | K180054 | Royal Flush Plus High-Flow Catheter Cook Incorporated | DQO |
| Sep 28, 2018 | K180216 | Seidmon Antegrade AQ Stent Set Cook Incorporated | FAD |
| Sep 21, 2018 | K180029 | Malecot Nephrostomy Catheter/Stent Set Cook Incorporated | FAD |
| Sep 14, 2018 | K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter Cook Incorporated | EYB |
| Sep 13, 2018 | K180053 | Sof-Flex Ureteral Stent Set Cook Incorporated | FAD |
| Aug 23, 2018 | K173657 | Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter Cook Incorporated | EZL |
| Aug 17, 2018 | K181713 | Ultraxx Nephrostomy Balloon Catheter Set Cook Incorporated | LJE |
Newest 50 of 365.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Cook Incorporated Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112 Open, Classified |
FBK | K171602 |
| May 1, 2026 | Cook Incorporated Beacon Tip Centimeter Sizing Catheter
RPN/GPN
NR5.0-35-70-P-10S-0-CSC-20
G31213
NR5.0-35-100-P-10S-0-CSC-20
G31214
NR5.0-35-100-P-10S-PIG-CSC-20
G31216
NR5.0-35-70-P-10S-VCF-CSC-20
G31220
NR5.0-35-100 Open, Classified |
DQO | K173289 |
| May 1, 2026 | Cook Incorporated Aurous Centimeter Sizing Catheter
RPN N5.0-35-100-P-10S-PIG-CSC-20-01
GPN G47308
Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic Open, Classified |
DQO | K162448 |
| May 1, 2026 | Cook Incorporated Centimeter Sizing Catheter
RPN N5.0-35-100-P-10S-PIG-CSC-20
GPN G11916
Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and d Open, Classified |
DQO | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537;
Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537;
Reference P Open, Classified |
JOL | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532;
Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535. Open, Classified |
JOL | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 Open, Classified |
GBX | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800;
Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G448 Open, Classified |
FOZ | K081113 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983;
Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754;
Reference Part Open, Classified |
FOZ | K033843 K081113 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250;
Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251. Open, Classified |
LQR | K173009 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 Open, Classified |
FGE | K173035 |
| Apr 6, 2026 | Cook Incorporated Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193;
Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665. Open, Classified |
BWC | K010016 K160200 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108 Open, Classified |
LQR | K173687 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424;
Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G Open, Classified |
FOZ | K081113 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073 Open, Classified |
JOH | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092;
Reference Part Number C-PTIS-100-HC, Order Number G12115. Open, Classified |
JOH | K133597 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703;
Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Numbe Open, Classified |
JOH | K193133 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685;
Reference Part Number C-PTIS-100-HC-G-NA, Order Number G5768 Open, Classified |
JOH | K193133 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419 Open, Classified |
DQO | K180846 |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792 Open, Classified |
DQX | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791 Open, Classified |
DQX | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 Open, Classified |
DQX | K171897 |
| Dec 23, 2025 | Cook Incorporated Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100;
The Rsch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional Open, Classified |
DYB | K171820 |
| Dec 23, 2025 | Cook Incorporated Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers:
1) RTPS-100;
2) RTPS-100-10.0;
The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagno Open, Classified |
DYB | K171820 |
| Dec 23, 2025 | Cook Incorporated Flexor Check-Flo Introducers and Sets, Reference Part Numbers:
1) KCFW-9.0-18/38-45-RB-ANL0-HC;
2) KCFW-9.0-18/38-45-RB-ANL1-HC;
3) KCFW-10.0-35-45-RB-HFANL0-HC;
4) KCFW-10.0-35-45-RB-HFANL1-HC; Open, Classified |
DYB | K142829 |
| Jun 16, 2025 | Cook Incorporated Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft len Open, Classified |
DQO | K173289 |
| May 16, 2025 | Cook Incorporated Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957, Open, Classified |
DYB | None listed |
| May 16, 2025 | Cook Incorporated Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686, Open, Classified |
DYB | K171999 |
| May 14, 2025 | Cook Incorporated Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2- Open, Classified |
KRD | None listed |
| Nov 21, 2024 | Cook Incorporated Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 Open, Classified |
DQX | K171897 |
| Nov 8, 2024 | Cook Incorporated Approach Hydro ST Micro Wire Guide; Catalog prefix HMW
Reference Part Numbers:
HMW-14-135-ST
HMW-14-190-ST
HMW-14-300-ST Open, Classified |
DQX | K091385 |
| Nov 8, 2024 | Cook Incorporated Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW;
Reference Part Numbers:
CMW-14-190-12G
CMW-14-190-18G
CMW-14-190-25G
CMW-14-190-6G
CMW-14-300-12G
CMW-14-300-18G
CMW-14-300-25G
CMW-14-3 Open, Classified |
DQX | K171897 |
| Oct 9, 2024 | Cook Incorporated Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with Open, Classified |
DYB | K171999 |
| Jun 27, 2024 | Cook Incorporated Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and Open, Classified |
FGE | K173035 |
| Jun 27, 2024 | Cook Incorporated Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and absce Open, Classified |
FGE | K173035 |
| Apr 12, 2024 | Cook Incorporated Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary an Open, Classified |
FGE | K183036 |
| Apr 12, 2024 | Cook Incorporated Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the Open, Classified |
FGE | K183036 |
| Apr 12, 2024 | Cook Incorporated Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary a Open, Classified |
FGE | K183036 |
| Apr 12, 2024 | Cook Incorporated Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.
REFERE Open, Classified |
FGE | K152524 |
| Apr 12, 2024 | Cook Incorporated Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use.
REFE Open, Classified |
DYB | None listed |
| Apr 12, 2024 | Cook Incorporated Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis.
REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH
ORDER NUMBER Open, Classified |
GCB | None listed |
| Apr 12, 2024 | Cook Incorporated Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal Open, Classified |
DRC | None listed |
| Apr 12, 2024 | Cook Incorporated Chiba Biopsy Needle - Used for aspiration biopsy.
REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN):
1) DCHN-18-10.0 G01559
2) DCHN-18-10.0-U G05040
3) DCHN-18-15.0 G00850
4) DCHN-22-10.0 G00852
5) DCH Open, Classified |
MJG | None listed |
| May 10, 2023 | Cook Incorporated Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721 Open, Classified |
JOH | K193133 |
| May 10, 2023 | Cook Incorporated Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PT Open, Classified |
JOH | K193133 |
| Sep 28, 2022 | Cook Incorporated Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY)
Reference Part Number/GPN
TMT-35-145 G01677 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire
Reference Part Number/GPN
TCMTNA-35-145-3 G01678 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Lunderquist -Ring Torque Wire Guide, Guidewire
Reference Part Number/GPN
THSF-35-125-THG G27031
THSF-35-145-THG G27033 Open, Classified |
DQX | K171764 |
| Sep 28, 2022 | Cook Incorporated Vinyl Connecting Tube, Connecting Tube
Reference Part Number/GPN
CTU14.0-30-ST G02278
CTU14.0-40-ST G02327
CTU14.0-30 G02791
CTU14.0-50-ST G02464
C-CTU14.0-30-ST G02898 Open, Classified |
GCD | None listed |
| Sep 28, 2022 | Cook Incorporated Torq-Flex Wire Guide Australian Modification, Guidewire
Reference Part Number/GPN
STF-18-40-AUST G07304 Open, Classified |
DQX | K171997 |
Newest 50 of 650.