Clearance Summary
Syringe with safety needle, Safety needle received FDA 510(k) clearance under submission number K193526, sponsored by Jiangsu Caina Medical Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2020-07-17.
- Submission: K193526
- Applicant / Sponsor: Jiangsu Caina Medical Co.,Ltd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2020-07-17
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.