K920582 is an FDA 510(k) clearance for the 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.. This device is classified as a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II - Special Controls, product code HQE).
Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on May 8, 1992, 88 days after receiving the submission on February 10, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K920582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1992 |
| Decision Date | May 08, 1992 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |