Endomina EZFuse system
K-Number: K252400 · 2026-02-13
ApplicantEndo Tools Therapeutics S.A.
Decision Date2026-02-13
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Endomina EZFuse system is a medical device manufactured by Endo Tools Therapeutics S.A.. It received FDA 510(k) clearance on 2026-02-13 under approval number K252400. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Endomina EZFuse system?
Endomina EZFuse system is a medical device that received FDA 510(k) clearance on 2026-02-13. It is manufactured by Endo Tools Therapeutics S.A.. The 510(k) number is K252400.
When was Endomina EZFuse system approved by the FDA?
Endomina EZFuse system received FDA 510(k) clearance on 2026-02-13, under approval number K252400.
What company makes Endomina EZFuse system?
Endomina EZFuse system is manufactured by Endo Tools Therapeutics S.A..
What is the FDA product code for Endomina EZFuse system?
The FDA product code for Endomina EZFuse system is OCW.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.