510(k) K132015 ยท HIH Hysteroscope (And Accessories)
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Dec 13, 2013 |
| Received | Jul 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132015
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2022 | Covidien Llc TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal.
Model Number: 7209808 Open, Classified |
HIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.