K220204 is an FDA 510(k) clearance for the Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on July 14, 2022, 170 days after receiving the submission on January 25, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K220204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2022 |
| Decision Date | July 14, 2022 |
| Days to Decision | 170 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 |