K210232 is an FDA 510(k) clearance for the Sterile Hypodermic Needles for Single Use. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Zhejiang Kangkang Medical-Devices Co., Ltd. (Yuhuan, CN). The FDA issued a Cleared decision on September 23, 2021, 238 days after receiving the submission on January 28, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K210232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2021 |
| Decision Date | September 23, 2021 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |