# K180138: AtriCure cryoICE cryo-ablation probe (CRYO2)

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Feb 15, 2018 after 29 days
- Product code: GXH (Device, Surgical, Cryogenic)
- Device class: 2
- Regulation: 21 CFR 882.4250
- 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.
4 later devices descend from it; 2 cite it directly.
0 of 59 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.

## Most influential descendants
- K182565: AtriCure cryoICE cryoSPHERE cryoablation probe (2018), 3 descendants of its own
- K200697: AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (2020), 2 descendants of its own
- K250371: cryoICE cryoXT cryoablation probe (cryoXT) (2025), 0 descendants of its own
- K233170: cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX  Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX  Cryoablation Probe (CRYOSMAX-L) (2023), 0 descendants of its own

## 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. The probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.

Source page: https://510kreport.com/device/K180138
Methodology: https://510kreport.com/methodology