K211334 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 Pharmaceuticals, Inc. (Fremont, US). The FDA issued a Cleared decision on September 10, 2021, 130 days after receiving the submission on May 3, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4250.
| 510(k) Number | K211334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2021 |
| Decision Date | September 10, 2021 |
| Days to Decision | 130 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 |