# Gyneco, Inc.

- Location (FDA's records): Somerville, NJ
- FDA decisions: 5 (1984–1986): 5 510(k) clearances
- Product codes: LDF (1), HFB (1), HHK (1), DRM (1), HFE (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)

## Its most-cited devices
- K841275: Fine Needle Aspiration Device (1984), cited by 1

## Recent decisions
- K861409: Syncare Temporary Cardiac Pacing Wire (May 5, 1986)
- K853216: Master Endomet Biopsy Kit W/Plas Cure 3,4MM-4003,4 (Apr 2, 1986)
- K852357: Gyne-Shear Cervical Biopsy Instrument W/Dispis Tip (Jul 5, 1985)
- K843941: Endocyte (Feb 25, 1985)
- K841275: Fine Needle Aspiration Device (Aug 17, 1984)

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