K210914 is an FDA 510(k) clearance for the Sterile Syringe for Single Use. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Jiangsu Suyun Medical Material Co., Ltd. (Lianyungang, CN). The FDA issued a Cleared decision on December 17, 2021, 263 days after receiving the submission on March 29, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K210914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2021 |
| Decision Date | December 17, 2021 |
| Days to Decision | 263 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 |