K922378 is an FDA 510(k) clearance for the OPHTHALMIC KNIFE. This device is classified as a Knife, Ophthalmic (Class I - General Controls, product code HNN).
Submitted by Microptics Development Laboratory (Newport Beach, US). The FDA issued a Cleared decision on December 10, 1992, 204 days after receiving the submission on May 20, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K922378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 1992 |
| Decision Date | December 10, 1992 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HNN — Knife, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |