# K152337: cryoFORM cryoICE cryoablation probe

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Mar 22, 2016 after 216 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: 14 generations back to K942299 (1995). 54 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142203: Atricure Cryo Module System; cryoICE cryoablation probe, AtriCure, Inc. (2014) Summary page 4.
- K970496: Heartport Maze System: Cryoprobe Set, Heartport, Inc. (1997) Summary page 4.

## Most influential descendants
- K251928: CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) (2026), 0 descendants of its own
- K180137: AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) (2018), 0 descendants of its own

## Indications for use
AtriCure’s cryoICE cryoFORM cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.

Source page: https://510kreport.com/device/K152337
Methodology: https://510kreport.com/methodology