510(k) K911160 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305
| Applicant | Mentor O & O, Inc., Norwell MA, US |
| Decision | Substantially Equivalent, May 2, 1991 |
| Received | Mar 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911160
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered
Model Number: 221265 Open, Classified |
GEI | None listed |
| Apr 26, 2022 | Beaver Visitec International, Inc. BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current
Part Number: 221251 Open, Classified |
GEI | None listed |
| Feb 26, 2018 | Beaver-Visitec International Inc. WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270.
Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedu Terminated |
GEI | None listed |
| Feb 26, 2018 | Beaver-Visitec International Inc. Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.