510(k) K191281 ยท HIH Hysteroscope (And Accessories)
Omni Hysteroscope, Omni Lok cervical seal
| Applicant | Hologic, Inc., Malborough MA, US |
| Decision | Substantially Equivalent, Aug 29, 2019 |
| Received | May 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191281
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.