K212544 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 October 13, 2021, 62 days after receiving the submission on August 12, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K212544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2021 |
| Decision Date | October 13, 2021 |
| Days to Decision | 62 days |
| Submission Type | Special |
| 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 |