# Gynecare Center

- Location (FDA's records): Somerville, NJ
- FDA decisions: 1 (2001–2001): 1 510(k) clearance
- Product codes: OTN (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: 0 (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)
- Herniamesh S.R.L.: 1 (https://510kreport.com/company/herniamesh)
- Cl Medical: 1 (https://510kreport.com/company/cl-medical)

## Its most-cited devices
- K012628: Gynecare Tension-Free Vaginal Tape System (2001), cited by 4

## Recent decisions
- K012628: Gynecare Tension-Free Vaginal Tape System (Oct 26, 2001)

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