Company · US
Wilson-Cook Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2026. Name variants (Inc, Corp, punctuation) are merged.
127510(k) clearances (1 in 12 months)
45recalls (4 in 12 months)
35recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 35 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 14 |
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | 11 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 8 |
| FCG | Biopsy Needle | 6 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 5 |
| FDX | Endoscopic Cytology Brush | 5 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 5 |
| ESW | Prosthesis, Esophageal | 4 |
| KNQ | Dilator, Esophageal | 4 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 4 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 3 |
| FDI | Snare, Flexible | 3 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 3 |
| GAA | Needle, Aspiration And Injection, Disposable | 3 |
| KGE | Forceps, Biopsy, Electric | 3 |
| LQR | Dislodger, Stone, Biliary | 3 |
| FCK | Instrument, Biopsy, Suction | 2 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2026 | K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) Wilson-Cook Medical, Inc. | QAU |
| Sep 29, 2025 | K251104 | SureTome SW Sphincterotome with DomeTip Wilson-Cook Medical | KNS |
| Jan 17, 2025 | K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord Wilson-Cook Medical, Inc. | KNS |
| Apr 26, 2022 | K213483 | SnapLoc Wire Lock Wilson Cook Medical | ODC |
| Jan 20, 2022 | K213356 | Entuit PEG, Entuit PEGJ Wilson-Cook Medical, Inc. | PIF |
| Aug 25, 2021 | K212323 | Instinct Plus Endoscopic Clipping Device Wilson-Cook Medical, Inc. | PKL |
| Jun 17, 2020 | K201322 | Entuit Nasal Jejunal Feeding Tube Wilson-Cook Medical, Inc. | KNT |
| Jun 10, 2020 | K200972 | Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc. | QAU |
| Feb 27, 2020 | K200247 | Fusion Quattro Extraction Balloon Wilson-Cook Medical, Inc. | GCA |
| Jan 30, 2020 | K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord Wilson-Cook Medical, Inc. | KNS |
| Dec 13, 2019 | K193344 | Tri-Ex Extraction Balloon with Multiple Sizing Wilson-Cook Medical, Inc. | GCA |
| Nov 14, 2019 | K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes Wilson-Cook Medical, Inc. | FDX |
| Jul 18, 2019 | K191048 | AcuSnare Polypectomy Snare - Duckbill Wilson-Cook Medical, Inc. | FDI |
| May 29, 2019 | K183336 | Entuit PEG, Entuit PEGJ Wilson-Cook Medical, Inc. | KNT |
| Feb 8, 2019 | K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush Wilson-Cook Medical, Inc. | FDX |
| Feb 1, 2019 | K182319 | Glo-Tip Spray Catheter Wilson-Cook Medical, Inc. | OCX |
| Jan 25, 2019 | K182895 | Wilson-Cook Achalasia Balloon Wilson-Cook Medical, Inc. | PID |
| Oct 30, 2018 | K182381 | Wilson-Cook Mini Basket Wilson-Cook Medical, Inc. | LQR |
| Aug 24, 2018 | K173673 | AcuSnare Polypectomy Snare Wilson-Cook Medical, Inc. | FDI |
| Jul 6, 2018 | K173659 | Howell D.A.S.H Extraction Balloon with Multiple Sizing Wilson-Cook Medical, Inc. | GCA |
| May 7, 2018 | DEN170015 | Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc. | QAU |
| Mar 28, 2018 | K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory He Wilson-Cook Medical, Inc. | LQR |
| Mar 21, 2018 | K171973 | Captura® Disposable Hot Biopsy Forceps Wilson-Cook Medical, Inc. | KGE |
| Mar 20, 2018 | K171989 | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Wilson-Cook Medical, Inc. | ODD |
| Feb 21, 2018 | K163377 | Captura Disposable Bronchoscope Biopsy Forceps Wilson-Cook Medical, Inc. | EOQ |
| Dec 29, 2017 | K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush Wilson-Cook Medical, Inc. | FDX |
| Oct 13, 2017 | K171548 | Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Gradua Wilson-Cook Medical, Inc. | FGE |
| Sep 20, 2017 | K170292 | Tri-Ex Extraction Balloon With Multiple Sizing Wilson-Cook Medical, Inc. | GCA |
| Aug 4, 2017 | K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle Wilson-Cook Medical, Inc. | FCG |
| Jun 16, 2017 | K171223 | Quantum TTC Biliary Balloon Dilator Wilson-Cook Medical, Inc. | FGE |
| Jun 14, 2017 | K160890 | Howell Biliary Introducer Needle Wilson-Cook Medical, Inc. | FCG |
| Apr 27, 2017 | K162142 | Accessory Irrigation Adapter Wilson-Cook Medical, Inc. | ODC |
| Apr 6, 2017 | K153763 | Howell Biliary Aspiration Needle Wilson-Cook Medical, Inc. | FCK |
| Jun 20, 2016 | K160170 | Lehman Manometry Catheter Wilson-Cook Medical, Inc. | FFX |
| May 4, 2016 | K161203 | Soehendra Stent Retriever Wilson-Cook Medical, Inc. | FGE |
| Nov 5, 2014 | K142950 | Acrobat Calibrated Tip Wire Guide Wilson-Cook Medical, Inc. | OCY |
| Jun 20, 2014 | K141356 | ECHO TIP ULTRA FIDUCIAL NEEDLE Wilson-Cook Medical, Inc. | NEU |
| Oct 25, 2013 | K132809 | INSTINCT ENDOSCOPIC HEMOCLIP Wilson-Cook Medical, Inc. | PKL |
| Oct 9, 2012 | K122816 | AXCESS SOFT TIP WIRE GUIDE Wilson-Cook Medical, Inc. | OCY |
| Jul 19, 2011 | K111495 | COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K Wilson-Cook Medical, Inc. | FBK |
| Jul 19, 2010 | K101095 | DIRECT PERORAL CHOLANGIOSCOPY BALLOON Wilson-Cook Medical, Inc. | FGE |
| Jan 5, 2007 | K063677 | FUSION QUATTRO EXTRACTION BALLOON XL Wilson-Cook Medical, Inc. | GCA |
| Aug 5, 2005 | K052051 | OMNI SPHINCTEROTOME Wilson-Cook Medical, Inc. | KNS |
| May 11, 2005 | K043203 | WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE Wilson-Cook Medical, Inc. | KNT |
| Jul 2, 2004 | K040930 | ZILVER BILIARY STENT SYSTEM USW Wilson-Cook Medical, Inc. | FGE |
| Jun 25, 2004 | K040800 | WILOSN-COOK BILIARY DILATION BALLOON Wilson-Cook Medical, Inc. | FGE |
| May 20, 2004 | K040324 | WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH Wilson-Cook Medical, Inc. | FDX |
| May 7, 2004 | K040981 | USW NEEDLEKNIFE PAPILLOTOME Wilson-Cook Medical, Inc. | KNS |
| Feb 27, 2004 | K040129 | TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING Wilson-Cook Medical, Inc. | GCA |
| Feb 20, 2004 | K040151 | OASIS BILIARY STENT INTRODUCTION SYSTEM Wilson-Cook Medical, Inc. | FGE |
Newest 50 of 127.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Wilson-Cook Medical Inc. Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT
Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT
Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU
Software Version: N/A
Product Description: Hemostatic Open, Classified |
QAU | K253302 |
| Apr 13, 2026 | Wilson-Cook Medical Inc. Instinct Plus Endoscopic Clipping Device
REF: G58010
Rx Only, Sterile EO Open, Classified |
PKL | K212323 |
| Feb 13, 2026 | Wilson-Cook Medical Inc. Teslatome Bipolar Sphincterotomes
REF: TESLA-B2535-260
Model Number: G60784
UDI-DI code: 00827002607842
REF: TESLA-B2535-450
Model Number: G60785
UDI-DI code: 00827002607859
These devices are used f Open, Classified |
KNS | K243568 |
| Feb 5, 2026 | Wilson-Cook Medical Inc. Product Name: Nasal Jejunal Feeding Tube
REF: NJFT-10 Open, Classified |
KNT | K043203 |
| Dec 2, 2024 | Wilson-Cook Medical Inc. Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile. Open, Classified |
QAU | None listed |
| Oct 16, 2024 | Wilson-Cook Medical Inc. Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal Open, Classified |
QAU | K200972 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Dec 1, 2023 | Wilson-Cook Medical Inc. QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree Open, Classified |
FGE | K171223 |
| Jul 28, 2023 | Wilson-Cook Medical Inc. Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies. Open, Classified |
FFL | None listed |
| Jul 28, 2023 | Wilson-Cook Medical Inc. Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies. Open, Classified |
FFL | None listed |
| Jun 21, 2023 | Wilson-Cook Medical Inc. Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346 Open, Classified |
QAU | K200972 |
| Jun 21, 2023 | Wilson-Cook Medical Inc. Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663; Open, Classified |
QAU | K200972 |
| Feb 4, 2020 | Wilson-Cook Medical Inc. HEMO-10 Hemospray Endoscopic Hemostat Terminated |
QAU | None listed |
| Feb 4, 2020 | Wilson-Cook Medical Inc. HEMO-7 Hemospray Endoscopic Hemostat Terminated |
QAU | None listed |
| Jul 24, 2019 | Wilson-Cook Medical Inc. Hemospray Endoscopic Hemostat Terminated |
QAU | None listed |
| Jun 14, 2019 | Wilson-Cook Medical Inc. Acuject Variable Injection Needle Terminated |
FBK | K941305 |
| Jan 4, 2019 | Wilson-Cook Medical Inc. Acusnare Polypectomy (Duck Bill Shaped) Snare
Used with an electrosurgical unit for endoscopic polypectomy. Terminated |
KNS | K851958 |
| Dec 18, 2018 | Wilson-Cook Medical Inc. COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S Terminated |
FFF | None listed |
| Dec 18, 2018 | Wilson-Cook Medical Inc. COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S Terminated |
FFF | None listed |
| Dec 7, 2005 | Wilson-Cook Medical Inc Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable Single Use Only * Compatible Wire Guide: .035'' * Rx Only * Wilson-Cook Medical * GI Endosc Terminated |
FGY | None listed |
| Jun 28, 2005 | Wilson-Cook Medical Inc Low Profile Gatrostomy - Contents include: Passport & Obturator * Disposable Single Use Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105. Terminated |
KNT | K920579 |
| Jun 28, 2005 | Wilson-Cook Medical Inc CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx On Terminated |
FGE | K851962 |
| Apr 8, 2005 | Wilson-Cook Medical Inc BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators * Catheter Diameter: 7 FR. Catheter Length: 35 CM. Disposable Single Use Only * Sterile/EO * Rx Only * Wilson Co Terminated |
GCJ | K990145 |
| Apr 8, 2005 | Wilson-Cook Medical Inc ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2 Terminated |
GCJ | K011016 |
| Aug 26, 2004 | Wilson-Cook Medical Inc Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethan Terminated |
ESW | K920218 |
| Jul 20, 2004 | Wilson-Cook Medical Inc Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable Single Use Only, Rx Only***COOK Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 2710 Terminated |
FPD | K874393 |
| Jul 20, 2004 | Wilson-Cook Medical Inc Biliary Stent Introducer Set Terminated |
FGE | K851962 |
| Jul 20, 2004 | Wilson-Cook Medical Inc AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. The SASM device prefix denotes Soft AcuSnare Mini. The ASM device prefix denote Terminated |
FDI | K851958 |
| Jul 20, 2004 | Wilson-Cook Medical Inc Four Shooter Saeed Multi-Band Ligator Terminated |
FHN | K944220 |
| Jan 14, 2004 | Wilson-Cook Medical Inc Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separat Terminated |
FGE | K851962 |
| Jan 7, 2004 | Wilson-Cook Medical Inc Howell D.A.S.H. II Access System, Wire Guided Sphincterotome Terminated |
KNS | K901443 |
| Nov 6, 2003 | Wilson-Cook Medical Inc ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Si Terminated |
FGE | K020788 |
| Oct 31, 2003 | Wilson-Cook Medical Inc APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Chann Terminated |
FGE | None listed |
| Oct 31, 2003 | Wilson-Cook Medical Inc EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum E Terminated |
FCG | K013356 |
| Oct 24, 2003 | Wilson-Cook Medical Inc Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Terminated |
GCA | K953951 |
| Oct 22, 2003 | Wilson-Cook Medical Inc Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035''/480 cm. Disposable Single use only, Rx Only. Cook, Wilson-Co Terminated |
FEG | K900035 |
| Oct 15, 2003 | Wilson-Cook Medical Inc Quantum TTC Biliary Balloon Dilator Terminated |
KNQ | K935094 |
| Aug 26, 2003 | Wilson-Cook Medical Inc Zilver Expandable Metal Biliary Stent Terminated |
FGE | K020788 |
| Aug 26, 2003 | Wilson-Cook Medical Inc Za-Stent Expandable Metal Biliary Stent Terminated |
FGE | K941350 |
| Aug 26, 2003 | Wilson-Cook Medical Inc Spiral Z Expandable Metal Biliary Stent Terminated |
FGE | K941350 |