K223373 is an FDA 510(k) clearance for the Enivo™. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Aroa Biosurgery , Ltd. (Mangere, NZ). The FDA issued a Cleared decision on April 7, 2023, 154 days after receiving the submission on November 4, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K223373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2022 |
| Decision Date | April 07, 2023 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | BTA - Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |