Clearance Summary
Enivo received FDA 510(k) clearance under submission number K223373, sponsored by Aroa Biosurgery , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-04-07.
- Submission: K223373
- Applicant / Sponsor: Aroa Biosurgery , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2023-04-07
Classification & Regulation
This clearance is catalogued under FDA product code BTA and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.