# Gynecare, Inc.

- Location (FDA's records): Menlo Park, CA
- FDA decisions: 4 (1996–2000): 3 510(k) clearances and 1 original PMA approval
- Product codes: HIH (3), MNB (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Gyrus Medical, Inc.: 2 (https://510kreport.com/company/gyrus-medical)
- Meditrina, Inc.: 1 (https://510kreport.com/company/meditrina)
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)

## Its most-cited devices
- K962482: Scuba System (1996), cited by 3
- K982738: Versapoint Electrosurgery System (Scuba) (1999), cited by 1

## Recent decisions
- K992901: Gynecare Versapoint G-Vap Electrode (Jan 18, 2000)
- K982738: Versapoint Electrosurgery System (Scuba) (Mar 1, 1999)
- P970021: Thermachoice Uterine Balloon Therapy (Ubt) System (Dec 12, 1997)
- K962482: Scuba System (Nov 1, 1996)

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