K210991 is an FDA 510(k) clearance for the Disposable Sterile Syringe, Disposable Sterile Syringe with Needle. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Guangdong Antmed Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on August 26, 2021, 146 days after receiving the submission on April 2, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K210991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2021 |
| Decision Date | August 26, 2021 |
| Days to Decision | 146 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 |