510(k) K250742 ยท GEH Unit, Cryosurgical, Accessories
Focused Cryotherapy System
| Applicant | Focused Cryo, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Dec 9, 2025 |
| Received | Mar 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250742
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.