K942642 is an FDA 510(k) clearance for the SURGI-WIPE. This device is classified as a Sponge, Ophthalmic (Class II - Special Controls, product code HOZ).
Submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on July 15, 1994, 42 days after receiving the submission on June 3, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4790.
| 510(k) Number | K942642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1994 |
| Decision Date | July 15, 1994 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HOZ — Sponge, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4790 |