K212226 is an FDA 510(k) clearance for the DR Safety Syringe, Sterile Hypodermic needle for Single use. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Zhuhai DR Medical Instruments Co., Ltd. (Zhuhai, CN). The FDA issued a Cleared decision on September 29, 2021, 75 days after receiving the submission on July 16, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K212226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2021 |
| Decision Date | September 29, 2021 |
| Days to Decision | 75 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 |