K203481 is an FDA 510(k) clearance for the CryoVIVE, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Recensmedical, Inc. (Hwaseong-Si, KR). The FDA issued a Cleared decision on May 13, 2021, 167 days after receiving the submission on November 27, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K203481 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 27, 2020 |
| Decision Date | May 13, 2021 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4350 |