K212207 is an FDA 510(k) clearance for the Sterile Hypodermic Syringe for Single Use. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Shandong Weigao Group Medical Polymer Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on March 23, 2023, 616 days after receiving the submission on July 15, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K212207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2021 |
| Decision Date | March 23, 2023 |
| Days to Decision | 616 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 |