K121675 is an FDA 510(k) clearance for the VERSAVIT. This device is classified as a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II - Special Controls, product code HQE).
Submitted by Synergetics, Inc. (O' Fallon, US). The FDA issued a Cleared decision on June 21, 2012, 15 days after receiving the submission on June 6, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K121675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2012 |
| Decision Date | June 21, 2012 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |