K890622 is an FDA 510(k) clearance for the SURG-E-TROL SYSTEM I AND SYSTEM II. This device is classified as a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II - Special Controls, product code HQE).
Submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on May 4, 1989, 86 days after receiving the submission on February 7, 1989.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K890622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1989 |
| Decision Date | May 04, 1989 |
| Days to Decision | 86 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 |