K896622 is an FDA 510(k) clearance for the VISITEC VITRECTOMY UNIT. This device is classified as a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II - Special Controls, product code HKP).
Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on April 4, 1990, 134 days after receiving the submission on November 21, 1989.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K896622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1989 |
| Decision Date | April 04, 1990 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HKP — Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |