K221066 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 Sichuan Prius Biotechnology Co., Ltd. (Yibin, CN). The FDA issued a Cleared decision on October 4, 2022, 175 days after receiving the submission on April 12, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K221066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2022 |
| Decision Date | October 04, 2022 |
| Days to Decision | 175 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 |