510(k) K254050 ยท HIH Hysteroscope (And Accessories)
Manual Tissue Removal Device
| Applicant | Suzhou AcuVu Medical Technology Co., Ltd., Suzhou, Jiangsu, CN |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Dec 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254050
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.