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CoolCryo Cryoapplicator for Cardiac Cryoablation (CC01-01); CoolCryo Control Console for Cardiac Cryoablation (CC01-21)

by Medinice S.A.

510(k) K251928

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251928 Date13 Feb 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
510(k) Number
FDA Product Code
GEH
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4350
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CoolCryo system comprises a cryosurgical device designed for cardiac cryoablation, classified as a unit, cryosurgical accessory. It employs extreme cold to create controlled tissue ablation, primarily used in the treatment of cardiac arrhythmias. The cryoapplicator (CC01-01) delivers localized freezing, while the control console (CC01-21) regulates cryogenic energy via liquid nitrogen.

The cryoapplicator is a sterile, single-use component intended for hospital operating rooms, operated by trained healthcare professionals. The control console is a reusable, nonsterile device with a liquid nitrogen reservoir, requiring proper storage and handling. Authorized under FDA 510(k) clearance (K251928) and regulated under 21 CFR 878.4350, the system adheres to Class II medical device standards. No MRI safety information or additional size specifications are provided.

From the manufacturer

CoolCryo is a cardiac cryoablation technology that uses liquid nitrogen as the cooling medium. Liquid nitrogen is widely available, commonly used, and one of the most cost-effective cooling agents, which significantly reduces the cost of the procedure and increases its accessibility.

Source: medinice.pl

Manufacturer's product page: CoolCryo

Other devices from Medinice S.A.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical application of the CoolCryo system, and how does it achieve its effect?

    The CoolCryo system is designed for cardiac cryoablation, a procedure used to treat cardiac arrhythmias by delivering controlled freezing to targeted tissue. The cryoapplicator (CC01-01) applies extreme cold to create localized tissue ablation, while the control console (CC01-21) regulates the cryogenic energy via liquid nitrogen. This precise freezing disrupts abnormal electrical pathways in the heart, helping restore normal rhythm.

  • Is the cryoapplicator reusable, or is it intended for single-use only? How does this affect its use in the operating room?

    The cryoapplicator (CC01-01) is explicitly labeled as a sterile, single-use component, meaning it must be discarded after one procedure. This design ensures patient safety by preventing cross-contamination and maintains sterility in the hospital operating room environment. The control console (CC01-21), however, is reusable and nonsterile, requiring proper cleaning and maintenance between uses.

  • What storage requirements apply to the CoolCryo system, particularly for the liquid nitrogen reservoir in the control console?

    The control console (CC01-21) includes a liquid nitrogen reservoir, which must be stored and handled according to cryogenic safety protocols. Since it is reusable and nonsterile, it requires proper containment, ventilation, and temperature control to prevent leaks or spills. The cryoapplicator (CC01-01), being single-use and sterile, should be stored in its original packaging until immediately before use, following manufacturer guidelines to preserve sterility.

  • Are there any size or model variations for the cryoapplicator, or is it a single standardized tool?

    The provided data does not specify size variations or distinct model numbers for the cryoapplicator (CC01-01) beyond its core function as a cryosurgical accessory for cardiac ablation. However, the system is classified under product code GEH (General, Plastic Surgery) and 21 CFR 878.4350, which may imply standardized sizing for cardiac procedures. For exact dimensions or model-specific details, consulting the manufacturer’s technical documentation is recommended.

  • How is the CoolCryo system regulated, and what does its FDA clearance status indicate about its safety and performance?

    The CoolCryo system holds FDA 510(k) clearance (K251928), classified as a Class II medical device under 21 CFR 878.4350. This clearance indicates that the manufacturer has demonstrated to the FDA that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. While this does not imply approval for specific clinical outcomes, it confirms that the system meets regulatory standards for use in cardiac cryoablation procedures when used as intended by trained professionals.