510(k) K243821 ยท HET Laparoscope, Gynecologic (And Accessories)
i-Cut
| Applicant | A.M.I. Agency For Medical Innovations GmbH, Feldkirch, AT |
| Decision | Substantially Equivalent, Apr 25, 2025 |
| Received | Dec 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243821
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.