K211555 is an FDA 510(k) clearance for the Hypodermic Safety Needle. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Anqing City, CN). The FDA issued a Cleared decision on October 18, 2021, 152 days after receiving the submission on May 19, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K211555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2021 |
| Decision Date | October 18, 2021 |
| Days to Decision | 152 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 |