Enivo
K-Number: K223373 · 2023-04-07
ApplicantAroa Biosurgery , Ltd.
Decision Date2023-04-07
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Enivo is a medical device manufactured by Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2023-04-07 under approval number K223373. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Enivo?
Enivo is a medical device that received FDA 510(k) clearance on 2023-04-07. It is manufactured by Aroa Biosurgery , Ltd.. The 510(k) number is K223373.
When was Enivo approved by the FDA?
Enivo received FDA 510(k) clearance on 2023-04-07, under approval number K223373.
What company makes Enivo?
Enivo is manufactured by Aroa Biosurgery , Ltd..
What is the FDA product code for Enivo?
The FDA product code for Enivo is BTA.
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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.