510(k) K182006 ยท HIH Hysteroscope (And Accessories)
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
| Applicant | Hologic, Inc., Malborough MA, US |
| Decision | Substantially Equivalent, Dec 6, 2018 |
| Received | Jul 27, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182006
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.