Enivo™
510(k) K223373
Enivo™ is a Class II device made by Aroa Biosurgery Ltd., cleared under FDA 510(k) K223373 on 7 Apr 2023, active as of 25 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223373 | Date7 Apr 2023 | StatusActive |
Official records
- FDA 510(k) database K223373
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BTA
- FDA applicant
- Aroa Biosurgery , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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