Clearance Summary
AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE received FDA 510(k) clearance under submission number K121637, sponsored by Sunwell Biotech 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 2012-10-25.
- Submission: K121637
- Applicant / Sponsor: Sunwell Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2012-10-25
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.