Clearance Summary
Sterile Auto-Disable Syringes with/without Needle for Single Use received FDA 510(k) clearance under submission number K210229, sponsored by Zhejiang Kangkang Medical-Devices 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 2022-02-15.
- Submission: K210229
- Applicant / Sponsor: Zhejiang Kangkang Medical-Devices Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2022-02-15
Classification & Regulation
This clearance is catalogued under FDA product code MEG and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.