510(k) K211334 ยท GXH Device, Surgical, Cryogenic
Iovera System
| Applicant | Pacira Pharmaceuticals, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Sep 10, 2021 |
| Received | May 3, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211334
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.