K210464 is an FDA 510(k) clearance for the Auto Disable Syringe. 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 August 24, 2021, 189 days after receiving the submission on February 16, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K210464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2021 |
| Decision Date | August 24, 2021 |
| Days to Decision | 189 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 |