K212949 is an FDA 510(k) clearance for the Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Henan Nursecare Biotechnology Co., Ltd. (Xinxiang, CN). The FDA issued a Cleared decision on February 24, 2022, 161 days after receiving the submission on September 16, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K212949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2021 |
| Decision Date | February 24, 2022 |
| Days to Decision | 161 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |