K221078 is an FDA 510(k) clearance for the Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Sichuan Prius Biotechnology Co., Ltd. (Yibin, CN). The FDA issued a Cleared decision on November 21, 2022, 223 days after receiving the submission on April 12, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K221078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2022 |
| Decision Date | November 21, 2022 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |