510(k) K962119 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
RE-NEW LAPAROSCOPIC INSTRUMENTS
| Applicant | Microline Pentax, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Aug 9, 1996 |
| Received | May 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962119
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2017 | Microline Surgical, Inc. ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115
The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indica Terminated |
GEI | None listed |
| 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.