K190002 is an FDA 510(k) clearance for the Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Shanghai Kohope Medical Devices Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 12, 2019, 253 days after receiving the submission on January 2, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K190002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2019 |
| Decision Date | September 12, 2019 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |