K234024 is an FDA 510(k) clearance for the HWJECT Auto-disable syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Anqing, CN). The FDA issued a Cleared decision on March 19, 2024, 90 days after receiving the submission on December 20, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K234024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2023 |
| Decision Date | March 19, 2024 |
| Days to Decision | 90 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 |