# Goulter Medical, Inc.

- Location (FDA's records): Concord, CA
- FDA decisions: 1 (1997–1997): 1 510(k) clearance
- Product codes: EYZ (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
- K964219: Zip Condom Catheter (Aug 11, 1997)

Source page: https://510kreport.com/company/goulter-medical