K223678 is an FDA 510(k) clearance for the Sterile Syringes for Single Use. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Shanghai Kindly Enterprise Development Group Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 9, 2023, 63 days after receiving the submission on December 8, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K223678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2022 |
| Decision Date | February 09, 2023 |
| Days to Decision | 63 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 |