K142203 is an FDA 510(k) clearance for the Atricure Cryo Module System. 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 November 25, 2014, 106 days after receiving the submission on August 11, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4250.
| 510(k) Number | K142203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2014 |
| Decision Date | November 25, 2014 |
| Days to Decision | 106 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 |