K853308 is an FDA 510(k) clearance for the KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000. This device is classified as a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II - Special Controls, product code HQE).
Submitted by Frigitronics of Connecticut, Inc. (Shelton, US). The FDA issued a Cleared decision on October 4, 1985, 58 days after receiving the submission on August 7, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K853308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1985 |
| Decision Date | October 04, 1985 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |