K954238 is an FDA 510(k) clearance for the SURGIN GENISIS HANDPIECE. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Surgin Surgical Instrumentation, Inc. (Temple City, US). The FDA issued a Cleared decision on December 8, 1995, 88 days after receiving the submission on September 11, 1995.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K954238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1995 |
| Decision Date | December 08, 1995 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |