# K251928: CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

- Pathway: 510(k) (Traditional)
- Applicant: Medinice S.A.
- Decided: Feb 13, 2026 after 235 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K942299 (1995). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152337: cryoFORM cryoICE cryoablation probe, AtriCure, Inc. (2016) Summary page 5.

## Indications for use
The CoolCryo cryoapplicator is a single use, sterile device indicated for the cryosurgical treatment for ablation of arrhythmic cardiac tissue by freezing target tissues, inducing an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The CoolCryo cryoapplicator can be used in adults and is intended for use in the clinical environment by trained healthcare professionals. The CoolCryo control console is a nonsterile, reusable device which delivers cryogenic energy, namely liquid nitrogen, to the CoolCryo cyroapplicator. The CoolCryo control console can be used in adults and is intended for use in the clinical environment by trained healthcare professionals.

Source page: https://510kreport.com/device/K251928
Methodology: https://510kreport.com/methodology