CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)— 510(k) K251928

Substantially Equivalent

Medinice S.A.

FDA 510(k) clearance K251928 for CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21), Substantially Equivalent on 2026-02-13. Applicant: Medinice S.A..

Clearance details

Applicant: Medinice S.A.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2025-06-23
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, PL

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.