510(k) K243677 · GXH Device, Surgical, Cryogenic
iovera° System
| Applicant | Pacira Biosciences, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 26, 2024 |
| Received | Nov 27, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243677
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.