K941495 is an FDA 510(k) clearance for the RETURN PATH DIATHERMY HANDLE. This device is classified as a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II - Special Controls, product code HQR).
Submitted by Mira, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 15, 1994, 109 days after receiving the submission on March 28, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4100.
| 510(k) Number | K941495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1994 |
| Decision Date | July 15, 1994 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQR — Apparatus, Cautery, Radiofrequency, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4100 |