# Enterix, Inc.

- Location (FDA's records): Edison, NJ
- FDA decisions: 3 (2001–2017): 3 510(k) clearances
- Product codes: KHE (3)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K170548: InSure ONE (Oct 5, 2017)
- K060930: Insure II (May 4, 2006)
- K002457: !Nsure Fecal Occult Blood Test (Jan 12, 2001)

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