510(k) K934320 ยท HQR Apparatus, Cautery, Radiofrequency, Ac-Powered
MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION
| Applicant | Mentor O & O, Inc., Norwell MA, US |
| Decision | Substantially Equivalent, Feb 16, 1994 |
| Received | Sep 3, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934320
| 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.