K211482 is an FDA 510(k) clearance for the Disposable Syringe with Needle. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Shandong Qinkai Medical Industry Co., Ltd. (Heze City, CN). The FDA issued a Cleared decision on January 24, 2022, 257 days after receiving the submission on May 12, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K211482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2021 |
| Decision Date | January 24, 2022 |
| Days to Decision | 257 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 |