510(k) K152143 ยท HIH Hysteroscope (And Accessories)
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Sep 2, 2015 |
| Received | Aug 3, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152143
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.