510(k) K211227 ยท HIH Hysteroscope (And Accessories)
HTx Disposable Hysteroscope System
| Applicant | Acuvu, Inc., Los Altos CA, US |
| Decision | Substantially Equivalent, Sep 15, 2021 |
| Received | Apr 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211227
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.