K971538 is an FDA 510(k) clearance for the MENTOR GEMINI HEMOSTATIC ERASER. This device is classified as a Unit, Cautery, Thermal, Ac-powered (Class II - Special Controls, product code HQO).
Submitted by Mentor Ophthalmics, Inc. (Norwell, US). The FDA issued a Cleared decision on July 14, 1997, 77 days after receiving the submission on April 28, 1997.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4115.
| 510(k) Number | K971538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 1997 |
| Decision Date | July 14, 1997 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQO — Unit, Cautery, Thermal, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4115 |