# Omega Surgical Instruments, Inc.

- Location (FDA's records): Fenton, MI
- FDA decisions: 3 (1993–1994): 3 510(k) clearances
- Product codes: GFA (2), HTY (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K941434: K-Wires and Steinmann Pins (Oct 3, 1994)
- K933595: Bur, Surgical, General & Plastic Surgery (Mar 16, 1994)
- K933298: Saw Blade (Aug 9, 1993)

Source page: https://510kreport.com/company/omega-surgical-instruments