Company · US
CooperSurgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2026. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (1 in 12 months)
87recalls (2 in 12 months)
72recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | 15 |
| MQL | Media, Reproductive | 12 |
| LKF | Cannula, Manipulator/Injector, Uterine | 10 |
| HEW | Culdoscope (And Accessories) | 8 |
| HHW | Pessary, Vaginal | 7 |
| HIH | Hysteroscope (And Accessories) | 7 |
| PUB | Accessory, Assisted Reproduction, Exempt | 7 |
| IMD | Pack, Hot Or Cold, Disposable | 6 |
| HIB | Speculum, Vaginal, Nonmetal | 5 |
| MQG | Accessory, Assisted Reproduction | 4 |
| HDW | Diaphragm, Contraceptive (And Accessories) | 3 |
| HEE | Set, Anesthesia, Paracervical | 3 |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 |
| MQE | Needle, Assisted Reproduction | 3 |
| MQF | Catheter, Assisted Reproduction | 3 |
| BZD | Ventilator, Non-Continuous (Respirator) | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| HEX | Colposcope (And Colpomicroscope) | 2 |
| HHM | Sound, Uterine | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 2026 | K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) CooperSurgical, Inc. | MQG |
| Aug 29, 2025 | K243799 | Fetal Pillow CooperSurgical, Inc. | PWB |
| Apr 11, 2025 | K250438 | CooperSurgical Milex® Pessaries CooperSurgical, Inc. | HHW |
| Oct 28, 2022 | K223064 | ALLY II Uterine Positioning System (UPS) CooperSurgical, Inc. | LKF |
| May 21, 2020 | K201086 | Advincula Delineator Uterine Manipulator CooperSurgical, Inc. | HEW |
| Feb 5, 2020 | K200038 | Endosee System CooperSurgical, Inc. | HIH |
| Jan 14, 2020 | K191020 | G210 InviCell Plus with SignipHy pH monitoring CooperSurgical, Inc. | PUB |
| Jun 12, 2019 | K191291 | Wallace Dual Lumen Oocyte Recovery System CooperSurgical, Inc. | MQE |
| May 15, 2019 | K190639 | Endosee System CooperSurgical, Inc. | HIH |
| May 10, 2019 | K182959 | Wallace Dual Lumen Oocyte Recovery System CooperSurgical, Inc. | MQE |
| Jan 31, 2019 | K183020 | Endosee System CooperSurgical, Inc. | HIH |
| Mar 14, 2018 | K180429 | Advincula Delineator Uterine Manipulator CooperSurgical, Inc. | HEW |
| Mar 2, 2018 | K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) CooperSurgical, Inc. | MQL |
| Jul 13, 2017 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula CooperSurgical, Inc. | HIH |
| Apr 4, 2017 | K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming Kit CooperSurgical, Inc. | MQL |
| Mar 18, 2016 | K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) CooperSurgical, Inc. | MPO |
| Dec 21, 2015 | K153092 | Ally Uterine Positioning System CooperSurgical, Inc. | LKF |
| Jul 21, 2015 | K143650 | CooperSurgical Advincula Delineator Uterine Manipulator CooperSurgical, Inc. | HEW |
| Feb 26, 2015 | K143415 | Air Bubble Based Infuser (ABBI) CooperSurgical, Inc. | LKF |
| Nov 25, 2014 | K141523 | ALLY UPS CooperSurgical, Inc. | LKF |
| Oct 23, 2014 | K140754 | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM CooperSurgical, Inc. | HEX |
| Jan 23, 2008 | K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS CooperSurgical, Inc. | HDW |
| Apr 10, 2003 | K021237 | COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS CooperSurgical, Inc., DE | HET |
| Jan 22, 2003 | K023930 | COOPERSURGICAL OOCYTE RECOVERY NEEDLES CooperSurgical, Inc. | MQE |
| Jul 26, 1999 | K990350 | WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316 CooperSurgical, Inc. | MQF |
| Jul 26, 1999 | K990349 | WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST CooperSurgical, Inc. | MQF |
| Jul 26, 1999 | K990348 | WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N CooperSurgical, Inc. | MQF |
| Jun 11, 1999 | K990852 | COOPERSURGICAL INFRARED COAGULATOR CooperSurgical, Inc. | KNS |
| Jun 1, 1999 | K990850 | COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL CooperSurgical, Inc. | KNS |
| Mar 30, 1999 | K990855 | COOPERSURGICAL INFRARED COAGULATOR FOR ENT CooperSurgical, Inc. | KNS |
| Feb 2, 1998 | K972630 | COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM CooperSurgical, Inc. | HEX |
| Nov 7, 1997 | K971836 | VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR CooperSurgical, Inc. | HET |
| Nov 5, 1997 | K971838 | MICRO ELECTRODES CooperSurgical, Inc. | KNF |
| Aug 6, 1997 | K971837 | VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820 CooperSurgical, Inc. | HET |
| Nov 19, 1996 | K954311 | KOH COLPOTOMIZER SYSTEM CooperSurgical, Inc. | HEW |
| Dec 11, 1995 | K951898 | VERSA-VU CooperSurgical, Inc. | HIB |
| Oct 6, 1995 | K952483 | LEEP SYSTEM 1000 CooperSurgical, Inc. | HGI |
| Mar 19, 1992 | K914108 | RG27-SERIES RESECTOSCOPE AND ACCESSORIES CooperSurgical, Inc. | HIH |
| Apr 19, 1991 | K910377 | COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM CooperSurgical, Inc. | GCX |
| Apr 18, 1991 | K910254 | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) CooperSurgical, Inc. | HHE |
| Apr 18, 1991 | K910253 | LEEP REDIKIT CooperSurgical, Inc. | HEE |
| Mar 4, 1991 | K910252 | POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE CooperSurgical, Inc. | HEE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | CooperSurgical, Inc. INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715. Open, Classified |
BZD | K911780 |
| Sep 18, 2026 | CooperSurgical, Inc. INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715. Open, Classified |
BZD | K911780 |
| Jul 18, 2025 | CooperSurgical, Inc. Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV.
Endosee System Convenience Kit with IV Tube. Open, Classified |
HIB | K920803 |
| Jul 18, 2025 | CooperSurgical, Inc. Endosee System Convenience Kit. Model Number: ES-TRAY.
Endosee System Convenience Kit Open, Classified |
HIB | K920803 |
| Jul 18, 2025 | CooperSurgical, Inc. HSG Procedure Tray. Model Number: 6050T.
The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures. Open, Classified |
HIB | K920803 |
| Dec 18, 2024 | CooperSurgical, Inc. Brand Name: K-Systems
Product Name: Multiple/unknown
Model/Catalog Number: Multiple/unknown
Software Version: N/A
Product Description: An electrically-powered device intended to provide suitable warmi Open, Classified |
PUB | None listed |
| Dec 18, 2024 | CooperSurgical, Inc. Brand Name: K-Systems
Product Name: R65 Trolley
Model/Catalog Number: K24012
Software Version: N/A
Product Description: An electrically-powered device intended to provide suitable warming and/or incub Open, Classified |
PUB | None listed |
| Dec 18, 2024 | CooperSurgical, Inc. Brand Name: K-Systems
Product Name: T47 Warming Plate
Model/Catalog Number: K23055
Software Version: N/A
Product Description: An electrically-powered device intended to provide suitable warming and/or Open, Classified |
PUB | None listed |
| Dec 18, 2024 | CooperSurgical, Inc. Brand Name: K-Systems
Product Name: T47 Warming Plate
Model/Catalog Number: K23054
Software Version: N/A
Product Description: An electrically-powered device intended to provide suitable warming and/or Open, Classified |
PUB | None listed |
| Dec 18, 2024 | CooperSurgical, Inc. Brand Name: K-Systems
Product Name: G85 Mini Incubator
Model/Catalog Number: K22074
Software Version: N/A
Product Description: An electrically-powered device intended to provide suitable warming and/o Open, Classified |
PUB | None listed |
| Dec 18, 2024 | CooperSurgical, Inc. Brand Name: K-Systems
Product Name: G73 Dry Bath Incubator
Model/Catalog Number: K22065
Product Description: An electrically-powered device intended to provide suitable warming and/or incubation condi Open, Classified |
PUB | None listed |
| Sep 26, 2024 | CooperSurgical, Inc. Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa.
Part Number: 84055060D Open, Classified |
MQL | K153267 |
| Sep 26, 2024 | CooperSurgical, Inc. Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa.
Part Number: 84055060A Open, Classified |
MQL | K153267 |
| Sep 26, 2024 | CooperSurgical, Inc. Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa
Part Number: 84051010A Open, Classified |
MQL | K153267 |
| Sep 20, 2024 | CooperSurgical, Inc. Stainless Steel Sims Uterine Sound, Part Number 64-601 Open, Classified |
HHM | None listed |
| Sep 20, 2024 | CooperSurgical, Inc. Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 Open, Classified |
HHM | None listed |
| Feb 14, 2024 | CooperSurgical, Inc. global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer. Open, Classified |
MQL | K142991 |
| Feb 5, 2024 | CooperSurgical, Inc. Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Th Open, Classified |
GCJ | K980123 |
| Dec 6, 2023 | CooperSurgical, Inc. CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet
Model: 61-4005S
For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology suc Open, Classified |
LKF | K013972 |
| Dec 6, 2023 | CooperSurgical, Inc. Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhe Open, Classified |
LKF | K013972 |
| Dec 6, 2023 | CooperSurgical, Inc. Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesio Open, Classified |
LKF | K961752 |
| Apr 6, 2023 | CooperSurgical, Inc. Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060 Open, Classified |
MQL | K142991 |
| Jan 31, 2023 | CooperSurgical, Inc. BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD) Open, Classified |
MQL | K060983 |
| Nov 10, 2022 | CooperSurgical, Inc. NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 Open, Classified |
JAY | None listed |
| Sep 28, 2022 | CooperSurgical, Inc. Humidifier bottle and syringe filter kit (6 count of each) for the BT37
Mark II Benchtop Incubator (AY200246) Open, Classified |
MQG | K121566 |
| Sep 28, 2022 | CooperSurgical, Inc. Humidifier bottle and syringe filter kit (6 count of each) for the BT37
Mark I Benchtop Incubator (AY102295).
The Mark I model is no longer produced, but the legacy humidifier
bottle component design Open, Classified |
MQG | K121566 |
| Jun 13, 2022 | CooperSurgical, Inc. LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 Open, Classified |
MQL | K092963 |
| Apr 1, 2022 | CooperSurgical, Inc. VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001
The VitriGuard device is a cryopreservation storage device composed of a stick and cap. Open, Classified |
MQK | K162833 |
| Sep 29, 2021 | CooperSurgical, Inc. Quantum 2000 Electrosurgical Generators
Cooper Surgical Part Number: 909075-05W Open, Classified |
HGI | K963653 |
| Sep 29, 2021 | CooperSurgical, Inc. Quantum 2000 Electrosurgical Generators
Cooper Surgical Part Number: 909075-05 Open, Classified |
HGI | K963653 |
| Sep 29, 2021 | CooperSurgical, Inc. Quantum 2000 Electrosurgical Generators
Cooper Surgical Part Number: 909075 Open, Classified |
HGI | K963653 |
| Sep 29, 2021 | CooperSurgical, Inc. LEEP PRECISION Generator 220V
Cooper Surgical Part Number: LP-20-220 Open, Classified |
HGI | K963653 |
| Sep 29, 2021 | CooperSurgical, Inc. LEEP PRECISION Generator 120V
Cooper Surgical Part Number: LP-20-120 Open, Classified |
HGI | K963653 |
| Sep 29, 2021 | CooperSurgical, Inc. LEEP PRECISION Integrated System, 220V
CooperSurgical part numbers: LP-10-220 Open, Classified |
HGI | K963348 |
| Sep 29, 2021 | CooperSurgical, Inc. LEEP PRECISION Integrated System, 120V
CooperSurgical part number: LP-10-120 Open, Classified |
HGI | K963348 |
| Jun 30, 2021 | CooperSurgical, Inc. Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers
Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 Terminated |
FMZ | None listed |
| Apr 30, 2021 | CooperSurgical, Inc. CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures Terminated |
GEI | K020711 |
| Apr 23, 2021 | CooperSurgical, Inc. The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex.
Model Number(s): KCP-30-2 Open, Classified |
HEW | K954311 |
| Feb 26, 2021 | CooperSurgical, Inc. Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2 Terminated |
HHW | K904774 |
| Sep 8, 2020 | CooperSurgical, Inc. MediCult Vitrification Cooling Media, Model Number 12284001F Terminated |
MQL | K100367 |
| Jun 3, 2020 | CooperSurgical, Inc. COOPERSURGICAL Os FinderTM Cervical Dilator,
Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm
Box of 50
Part Number: 1176 Terminated |
LOB | None listed |
| Apr 9, 2020 | CooperSurgical, Inc. CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21 Terminated |
HIH | K183020 |
| Feb 28, 2020 | CooperSurgical, Inc. Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the i Terminated |
MFD | K964848 |
| Dec 13, 2019 | CooperSurgical, Inc. ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5
The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of th Terminated |
HIH | K190639 |
| Oct 16, 2019 | CooperSurgical, Inc. Quantam 2000 Electrosurgical Generator, Part number 909075-05W. Terminated |
HGI | K963653 |
| Oct 16, 2019 | CooperSurgical, Inc. Quantam 2000 Electrosurgical Generator, Part number 909075-05. Terminated |
HGI | K963653 |
| Oct 16, 2019 | CooperSurgical, Inc. Quantam 2000 Electrosurgical Generator, Part number 909075. Terminated |
HGI | K963653 |
| Sep 5, 2019 | CooperSurgical, Inc. Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activit Terminated |
MQG | K160504 |
| Aug 19, 2019 | CooperSurgical, Inc. LEEP Return Patient Pads (10/ box)
Model # 6050Pl
used in electrosurgical procedures. Terminated |
GEI | K120476 |
| Jul 8, 2019 | CooperSurgical, Inc. TransWarmer Warming Infant Transport Mattress, Model no. 20421
Product Usage:
The TransWarmer Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two ho Terminated |
IMD | K934631 |
Newest 50 of 87.