Enivo™
K-Number: K223373 · 2023-04-07
Device Summary
Frequently Asked Questions
What is the Enivo™?
Enivo™ is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K223373.
When did Enivo™ receive FDA 510(k) clearance?
Enivo™ received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223373.
Who is the listed applicant for Enivo™?
The FDA 510(k) record lists Aroa Biosurgery , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Enivo™?
The FDA product code for Enivo™ is BTA.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Aroa Biosurgery , Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: BTA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.