# Bioenterics Corp.

- Location (FDA's records): Carpinteria, CA
- FDA decisions: 4 (1992–2001): 4 510(k) clearances
- Product codes: HMJ (2), FDG (1), KNT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (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
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Crospon, Ltd.: 1 (https://510kreport.com/company/crospon)
- Gabriel Medical, Inc.: 1 (https://510kreport.com/company/gabriel-medical)
- Stryker Endoscopy: 1 (https://510kreport.com/company/stryker-endoscopy)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Reshape Lifesciences: 1 (https://510kreport.com/company/reshape-lifesciences)

## Its most-cited devices
- K002838: Gastric Suction and Drainage Catheter (2001), cited by 3
- K934084: Bioenterics Endolumina Illuminating Bougie (1993), cited by 2
- K964561: Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR E-4020, Endolumina II Detachable Tips, 56FR, TA (1997), cited by 1

## Recent decisions
- K002838: Gastric Suction and Drainage Catheter (Jul 9, 2001)
- K964561: Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR E-4020, Endolumina II Detachable Tips, 56FR, TA (Feb 11, 1997)
- K934084: Bioenterics Endolumina Illuminating Bougie (Dec 16, 1993)
- K924753: Bioentrics Endolumina Illuminated Bougie (Dec 15, 1992)

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