510(k) K880863 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200
| Applicant | New England Surgical Instrument Corp., Rockland MA, US |
| Decision | Substantially Equivalent, Apr 19, 1988 |
| Received | Mar 1, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880863
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2014 | Alcon Research, Ltd. Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument f Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.