# Galenica Enterprises, Inc.

- Location (FDA's records): Quebec Canada J7e 4h7, CA
- FDA decisions: 5 (1984–1994): 5 510(k) clearances
- Product codes: HGG (1), FER (1), HIB (1), HIC (1), GDI (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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K923656: Lighting Source System (Sep 8, 1994)
- K896383: Disposable External Clamps (Dec 6, 1989)
- K883283: Disposable Amniotome (Oct 18, 1988)
- K861017: Galenica's Disposable Anoscopes (Jun 13, 1986)
- K841909: Vaginal Speculum - Disposable (Jul 31, 1984)

Source page: https://510kreport.com/company/galenica-enterprises