510(k) K100280 ยท HET Laparoscope, Gynecologic (And Accessories)
GYNCARE MORCELLEX TISSUE MORCELLATOR
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Mar 24, 2010 |
| Received | Feb 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100280
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.