510(k) K091010 ยท HET Laparoscope, Gynecologic (And Accessories)
TROKAMED MORCELLATOR
| Applicant | Trokamed GmbH, Amsterdam, Nh, NL |
| Decision | Substantially Equivalent, Mar 1, 2011 |
| Received | Apr 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091010
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2014 | Market-Tiers Inc Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, s Terminated |
HET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.