K222124 is an FDA 510(k) clearance for the Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Anqing City, CN). The FDA issued a Cleared decision on November 4, 2022, 109 days after receiving the submission on July 18, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K222124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2022 |
| Decision Date | November 04, 2022 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |