K211210 is an FDA 510(k) clearance for the Sterile Auto-Disable Syringes with/without Needle for Single Use. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Azur Medical Company, Inc. (Richmond, US). The FDA issued a Cleared decision on January 27, 2022, 279 days after receiving the submission on April 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K211210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2021 |
| Decision Date | January 27, 2022 |
| Days to Decision | 279 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 |