510(k) K974066 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS
| Applicant | Microline Pentax, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Jan 22, 1998 |
| Received | Oct 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974066
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2017 | Microline Surgical, Inc. The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic an Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.