# Sierra Laboratories, Inc.

- Location (FDA's records): Tucson, AZ
- FDA decisions: 12 (1979–1997): 12 510(k) clearances
- Product codes: EXJ (5), KBC (1), FAQ (1), KNX (1), BYN (1), EYT (1), EYZ (1), EFD (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
- K970966: Comfort Cath Choice Male External Catheter (Apr 22, 1997)
- K962384: Comfort Sheath Reusable Male External Catheter (Jul 15, 1996)
- K962413: Comfort Cath Special Self Adhering Male External Catheter (Jul 15, 1996)
- K934266: Comfort Cath Self Adhering Male External Catheter (Apr 19, 1994)
- K934052: Alpine Reusable Leg Bags (Jan 7, 1994)
- K931156: Cone Cath (Jul 1, 1993)
- K901000: Uro Tex Urinals (Mar 26, 1990)
- K883057: Comfort Cath Male External Catheter (Aug 2, 1988)

Source page: https://510kreport.com/company/sierra-laboratories