# K250371: cryoICE cryoXT cryoablation probe (cryoXT)

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Apr 10, 2025 after 59 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: 17 generations back to K942299 (1995). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200697: AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L), AtriCure, Inc. (2020) Summary page 5.

## Indications for use
AtriCure’s cryolCE cryoXT cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).

Source page: https://510kreport.com/device/K250371
Methodology: https://510kreport.com/methodology