510(k) K133272 ยท GCJ Laparoscope, General & Plastic Surgery
VERSACUT + TISSUE MORCELLATOR
| Applicant | Lumenis, Ltd., Binyamina, IL |
| Decision | Substantially Equivalent, May 13, 2014 |
| Received | Oct 24, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133272
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2015 | Lumenis Lumenis VersaCut+ Tissue Morcellator GA-0007500
The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and remova Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.