endomina system
K-Number: K211309 · 2021-12-07
ApplicantEndo Tools Therapeutics S.A.
Decision Date2021-12-07
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
endomina system is a medical device manufactured by Endo Tools Therapeutics S.A.. It received FDA 510(k) clearance on 2021-12-07 under approval number K211309. 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 system?
endomina system is a medical device that received FDA 510(k) clearance on 2021-12-07. It is manufactured by Endo Tools Therapeutics S.A.. The 510(k) number is K211309.
When was endomina system approved by the FDA?
endomina system received FDA 510(k) clearance on 2021-12-07, under approval number K211309.
What company makes endomina system?
endomina system is manufactured by Endo Tools Therapeutics S.A..
What is the FDA product code for endomina system?
The FDA product code for endomina 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.