K180259 is an FDA 510(k) clearance for the Sterile Hypodermic Needle for Single Use. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Jiangsu Shenli Medical Production Co., Ltd. (Changzhou City, CN). The FDA issued a Cleared decision on May 18, 2018, 108 days after receiving the submission on January 30, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K180259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2018 |
| Decision Date | May 18, 2018 |
| Days to Decision | 108 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 |