# Gynecare, A Div. of Ethicon, Inc.

- Location (FDA's records): Somerville, NJ
- FDA decisions: 2 (2002–2004): 2 510(k) clearances
- Product codes: OTO (1), HIH (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- ETHICON, Inc.: 2 (https://510kreport.com/company/ethicon)
- Mentor Corp.: 1 (https://510kreport.com/company/mentor)
- Mpathy Medical Devices, Ltd.: 1 (https://510kreport.com/company/mpathy-medical-devices)
- American Medical Systems, Inc.: 1 (https://510kreport.com/company/american-medical-systems)
- Sofradim Production: 1 (https://510kreport.com/company/sofradim-production)

## Its most-cited devices
- K013718: Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair (2002), cited by 6

## Recent decisions
- K040302: Versapoint Resectoscopic System (Mar 9, 2004)
- K013718: Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair (Jan 8, 2002)

Source page: https://510kreport.com/company/gynecare-a-div-of-ethicon