K221308 is an FDA 510(k) clearance for the Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Jiangxi Maidikang Medical Devices Co., Ltd. (Yichun, CN). The FDA issued a Cleared decision on October 17, 2022, 165 days after receiving the submission on May 5, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K221308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2022 |
| Decision Date | October 17, 2022 |
| Days to Decision | 165 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 |