K955158 is an FDA 510(k) clearance for the SURGITRON. This device is classified as a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II - Special Controls, product code HQR).
Submitted by Ellman Intl., Inc. (Sound Beach, US). The FDA issued a Cleared decision on February 9, 1996, 88 days after receiving the submission on November 13, 1995.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4100.
| 510(k) Number | K955158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1995 |
| Decision Date | February 09, 1996 |
| Days to Decision | 88 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 |