Clearance Summary
SINGLE USE STERILE SYRINGE WITH NEEDLE received FDA 510(k) clearance under submission number K133493, sponsored by Jiangxi Kelun Medical Devices Manufacturing Co.,Lt. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2014-03-27.
- Submission: K133493
- Applicant / Sponsor: Jiangxi Kelun Medical Devices Manufacturing Co.,Lt
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2014-03-27
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.