K212846 is an FDA 510(k) clearance for the Sterile Hypodermic Syringe for Single Use, with/without 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 Jichun Medical Devices Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on August 30, 2022, 357 days after receiving the submission on September 7, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K212846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2021 |
| Decision Date | August 30, 2022 |
| Days to Decision | 357 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 |