510(k) K955168 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
SURGICAL CUTTER
| Applicant | Promex, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 22, 1996 |
| Received | Nov 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955168
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2015 | Nico Corp. NICO Myriad Console
Model number NN-7000
The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and Terminated |
GEY | None listed |
| Feb 24, 2014 | Nico Corp. Myriad handpiece
Tissue morcellator Terminated |
GEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.