# CooperSurgical, Inc.

- Location (FDA's records): Trumbull, CT
- FDA decisions: 45 (1991–2026): 42 510(k) clearances and 3 original PMA approvals
- Product codes: HIH (5), LKF (4), HEW (4), HET (3), MQE (3), KNS (3), MQF (3), MNB (2), MQL (2), HEX (2), HEE (2), MUA (1)
- 510(k) review time since 2016: median 50 days, against 93 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 32 (9 its own); citations of its devices by later devices: 36 (9 its own)
- Recalls linked to its devices: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Leisegang Medical, Inc.: 2 (https://510kreport.com/company/leisegang-medical)
- Femasys, Inc.: 1 (https://510kreport.com/company/femasys)
- Sims Portex, Inc.: 1 (https://510kreport.com/company/sims-portex)
- Schoelly Fiberoptic GmbH: 1 (https://510kreport.com/company/schoelly-fiberoptic)
- Endosee Corp: 1 (https://510kreport.com/company/endosee)
- Endosec Corporation: 1 (https://510kreport.com/company/endosec)
- Planer Plc: 1 (https://510kreport.com/company/planer)
- Irvine Scientific: 1 (https://510kreport.com/company/irvine-scientific)

## Firms that cite its devices most
- Swemed Lab International AB: 3 (https://510kreport.com/company/swemed-lab-international)
- Wallach Surgical Devices, Inc.: 2 (https://510kreport.com/company/wallach-surgical-devices)
- Cooper Surgical: 2 (https://510kreport.com/company/cooper-surgical)
- Portex, Inc.: 2 (https://510kreport.com/company/portex)
- Gynex Corp.: 2 (https://510kreport.com/company/gynex)
- Lina Medical Aps: 1 (https://510kreport.com/company/lina-medical)
- International Biomedical: 1 (https://510kreport.com/company/international-biomedical)
- Insitu Systems: 1 (https://510kreport.com/company/insitu-systems)

## Its most-cited devices
- K954311: Koh Colpotomizer System (1996), cited by 6
- K990348: Wallace Trial Transfer Catheter, Model TT 1816N (1999), cited by 3
- K990350: Wallace Catheters-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316 (1999), cited by 3
- K910252: Potocky Neddle (TM) Disposable Injection Needle (1991), cited by 3
- K141523: Ally Ups (2014), cited by 2
- K190639: Endosee System (2019), cited by 2

## Recent decisions
- K261083: Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector  (WFC); Wallace® Vacuum Connection Kit  (WVCK) (Aug 19, 2026)
- K243799: Fetal Pillow (Aug 29, 2025)
- K250438: CooperSurgical Milex® Pessaries (Apr 11, 2025)
- K223064: ALLY II Uterine Positioning System™ (UPS) (Oct 28, 2022)
- K201086: Advincula Delineator Uterine Manipulator (May 21, 2020)
- K200038: Endosee System (Feb 5, 2020)
- K191020: G210 InviCell Plus with SignipHy pH monitoring (Jan 14, 2020)
- K191291: Wallace Dual Lumen Oocyte Recovery System (Jun 12, 2019)

Source page: https://510kreport.com/company/coopersurgical