Cleared Traditional

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

K251928 · Medinice S.A. · Cardiovascular
Feb 2026
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K251928 is an FDA 510(k) clearance for the CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21), 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 review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K251928 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GEH — Unit, Cryosurgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4350