K203264 is an FDA 510(k) clearance for the MicroDose Injector. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Medone Surgical, Inc. (Sarasota, US). The FDA issued a Cleared decision on April 26, 2021, 172 days after receiving the submission on November 5, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K203264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2020 |
| Decision Date | April 26, 2021 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |