# K200697: AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Dec 23, 2020 after 281 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: 16 generations back to K942299 (1995). 56 ancestors in all.
2 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)
- K180138: AtriCure cryoICE cryo-ablation probe (CRYO2), AtriCure, Inc. (2018) Summary page 5.
- K182565: AtriCure cryoICE cryoSPHERE cryoablation probe, AtriCure, Inc. (2018) Summary page 5.

## Most influential descendants
- 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
For Adult Patients AtriCure’s Cryo2 cryoICE 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. The Cryo2 cryoICE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves. For Adolescent Patients The Cryo2 cryoICE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age. 1Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology. For Adult Patients AtriCure’s cryoICE cryoSPHERE cryoablation probes are sterile, single use devices intended for use performed by freezing target tissues, creating an inflammatory response (cryonecrosis) for blocking pain by temporarily ablating peripheral nerves. For Adolescent Patients The cryoICE cryoSPHERE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age. 1Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.

Source page: https://510kreport.com/device/K200697
Methodology: https://510kreport.com/methodology