K200697 is an FDA 510(k) clearance for the AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L). This device is classified as a Device, Surgical, Cryogenic (Class II - Special Controls, product code GXH).
Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on December 23, 2020, 281 days after receiving the submission on March 17, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4250.
| 510(k) Number | K200697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2020 |
| Decision Date | December 23, 2020 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXH — Device, Surgical, Cryogenic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4250 |