K243677 is an FDA 510(k) clearance for the iovera° System. This device is classified as a Device, Surgical, Cryogenic (Class II - Special Controls, product code GXH).
Submitted by Pacira Biosciences, Inc. (San Diego, US). The FDA issued a Cleared decision on December 26, 2024, 29 days after receiving the submission on November 27, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4250.
| 510(k) Number | K243677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2024 |
| Decision Date | December 26, 2024 |
| Days to Decision | 29 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 |