K221073 is an FDA 510(k) clearance for the Sterile Hypodermic Syringes for Single Use with Safety Needles. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
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 880.5860.
| 510(k) Number | K221073 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 | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |