FDA applicant
Entrotech Life Sciences, Inc.
FDA records 1 decision for Entrotech Life Sciences, Inc. (Sunnyvale, CA) in 2014: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Entrotech Life Sciences, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2014high 1 (2014) · low 0 (2015)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Entrotech Life Sciences, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report