510(k) K254294 ยท HIH Hysteroscope (And Accessories)
Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
| Applicant | Zhejiang Geyi Medical Instrument Co., Ltd., Jiande City, CN |
| Decision | Substantially Equivalent, Sep 8, 2026 |
| Received | Dec 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254294
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.