K210229 is an FDA 510(k) clearance for the Sterile Auto-Disable Syringes with/without Needle for Single Use. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Zhejiang Kangkang Medical-Devices Co., Ltd. (Yuhuan, CN). The FDA issued a Cleared decision on February 15, 2022, 383 days after receiving the submission on January 28, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K210229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2021 |
| Decision Date | February 15, 2022 |
| Days to Decision | 383 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 |