510(k) K981389 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
DISPOSABLE RE-NEW FORCEPS
| Applicant | Microline Pentax, Inc., Wellesley MA, US |
| Decision | Substantially Equivalent, May 29, 1998 |
| Received | Apr 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981389
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2017 | Microline Surgical, Inc. ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989
The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are Terminated |
GEI | None listed |
| Jul 2, 2014 | Microline Surgical, Inc. Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips
Ref 3221 Terminated |
GEI | None listed |
| Jul 2, 2014 | Microline Surgical, Inc. Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable)
Ref 3222 Terminated |
GEI | None listed |
| May 20, 2014 | Microline Surgical Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222
The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue f Terminated |
GEI | None listed |
| Aug 29, 2011 | Microline Surgical, Inc. Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip
Ref: 3262
The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdominal tissue for us Terminated |
GEI | None listed |
| Aug 29, 2011 | Microline Surgical, Inc. Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip
Ref: 3642
The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdomin Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.