K210310 is an FDA 510(k) clearance for the CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Nuance Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on October 22, 2021, 261 days after receiving the submission on February 3, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K210310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2021 |
| Decision Date | October 22, 2021 |
| Days to Decision | 261 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 |