K251928

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

510(k) number: K251928
Device name: CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
Applicant: Medinice S.A. PL
Product code: GEH — Unit, Cryosurgical, Accessories
Decision date: 2026-02-13
Date received: 2025-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain

Also available from FDA: K251928.pdf

Official FDA record: K251928

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.