K934320 is an FDA 510(k) clearance for the MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION. This device is classified as a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II - Special Controls, product code HQR).
Submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on February 16, 1994, 166 days after receiving the submission on September 3, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4100.
| 510(k) Number | K934320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1993 |
| Decision Date | February 16, 1994 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQR — Apparatus, Cautery, Radiofrequency, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4100 |