Cleared Traditional

K251928 - CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01) (FDA 510(k) Clearance)

Also includes:
CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251928 · Medinice S.A. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
235d
Days
Class 2
Risk

K251928 is an FDA 510(k) clearance for the CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01). Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Medinice S.A. (Warsaw, PL). The FDA issued a Cleared decision on February 13, 2026 after a review of 235 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4350 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medinice S.A. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 125d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

MEDIcept
Melissa DeHass

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 260
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