K212857 is an FDA 510(k) clearance for the Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Jiangsu Zhiyu Medical Instrument Co, Ltd. (Taixing, CN). The FDA issued a Cleared decision on May 9, 2023, 608 days after receiving the submission on September 8, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K212857 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2021 |
| Decision Date | May 09, 2023 |
| Days to Decision | 608 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 |