K220603 is an FDA 510(k) clearance for the Disposable Medical Safety Hypodermic Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Hantech Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on August 23, 2022, 174 days after receiving the submission on March 2, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K220603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2022 |
| Decision Date | August 23, 2022 |
| Days to Decision | 174 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 |