# K182565: AtriCure cryoICE cryoSPHERE cryoablation probe

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Nov 9, 2018 after 52 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: 15 generations back to K942299 (1995). 55 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K180138: AtriCure cryoICE cryo-ablation probe (CRYO2), AtriCure, Inc. (2018) Summary page 4.

## Most influential descendants
- 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 cryoSPHERE cryoablation probes are sterile, single use devices intended for use in blocking pain by temporarily ablating peripheral nerves.

Source page: https://510kreport.com/device/K182565
Methodology: https://510kreport.com/methodology