K182565 is an FDA 510(k) clearance for the AtriCure cryoICE cryoSPHERE cryoablation probe. This device is classified as a Device, Surgical, Cryogenic (Class II - Special Controls, product code GXH).
Submitted by AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on November 9, 2018, 52 days after receiving the submission on September 18, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4250.
| 510(k) Number | K182565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2018 |
| Decision Date | November 09, 2018 |
| Days to Decision | 52 days |
| Submission Type | Special |
| 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 |