K211211 is an FDA 510(k) clearance for the Sterile syringes for single use with/without needle. 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 October 7, 2021, 167 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 | K211211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2021 |
| Decision Date | October 07, 2021 |
| Days to Decision | 167 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 |