K202432 is an FDA 510(k) clearance for the MiniLoad Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Ocuject, LLC (Newport Beach, US). The FDA issued a Cleared decision on February 19, 2021, 178 days after receiving the submission on August 25, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K202432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2020 |
| Decision Date | February 19, 2021 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |