K211753 is an FDA 510(k) clearance for the Sterile Syringe With Safety Needle. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Jiangxi Hongda Medical Equipment Group , Ltd. (Nanchang, CN). The FDA issued a Cleared decision on October 14, 2021, 129 days after receiving the submission on June 7, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K211753 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2021 |
| Decision Date | October 14, 2021 |
| Days to Decision | 129 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 |