K251928 is an FDA 510(k) clearance for the CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01). This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Medinice S.A. (Warsaw, PL). The FDA issued a Cleared decision on February 13, 2026, 235 days after receiving the submission on June 23, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K251928 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2025 |
| Decision Date | February 13, 2026 |
| Days to Decision | 235 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | GEH - Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |