# K180137: AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Feb 15, 2018 after 29 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). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142441: cryoICE croablation probe, AtriCure, Inc. (2014) Summary page 4.
- K152337: cryoFORM cryoICE cryoablation probe, AtriCure, Inc. (2016) Summary page 4.

## Indications for use
AtriCure’s cryoICE cryo-ablation 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/K180137
Methodology: https://510kreport.com/methodology