510(k) K253348 ยท GEH Unit, Cryosurgical, Accessories
TargetCool-e
| Applicant | Recensmedical, Inc., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Oct 15, 2025 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253348
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.