CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01) +1 more— 510(k) K251928
Substantially EquivalentMedinice S.A.
FDA 510(k) clearance K251928 for CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01) +1 more, Substantially Equivalent on 2026-02-13. Applicant: Medinice S.A.. Device class: 2.
Summary
Medinice lists two CoolCryo items: a cryoapplicator for cardiac cryoablation (CC01-01) and a control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21). They're filed under product code GEH (Unit, Cryosurgical, Accessories). The record doesn't describe them beyond those names.
Class II, 21 CFR 878.4350. The Cardiovascular review panel handled it as a Traditional 510(k), though the record lists General, Plastic Surgery as the classification panel.
Medinice filed from Warsaw, Poland. FDA found it substantially equivalent 235 calendar days after receipt (June 23, 2025 to February 13, 2026).
Clearance details
- Device name as filed
- CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
- Applicant
- Medinice S.A.
- Product code
- Product code GEH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4350
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, PL
Recent devices under product code GEH
view all- K260520 — Skin Clinic Nitro Clear for Warts and Skin Tags
- K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- K261068 — Maverix Cryo Biopsy Probe (MCB1000); Maverix Cryo Cartridge (CC1000)
- K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories
- K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
Source: openFDA MAUDE database, through . 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.