K212652 is an FDA 510(k) clearance for the Sterile Syringe with Fixed Safety Needle for Single Use. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Gemtier Medical (Shanghai), Inc. (Shanghai, CN). The FDA issued a Cleared decision on March 2, 2022, 191 days after receiving the submission on August 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K212652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2021 |
| Decision Date | March 02, 2022 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |