510(k) K050639 ยท GCJ Laparoscope, General & Plastic Surgery
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
| Applicant | Lumenis, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Mar 31, 2005 |
| Received | Mar 14, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050639
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2013 | Lumenis Limited The Lumenis VersaCut Tissue Morcellator
Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparosc Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.