Clearance Summary
U&U Insulin Syringe with/without Safety Retractable Device received FDA 510(k) clearance under submission number K152808, sponsored by U&U Medical Technology 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 2016-03-25.
- Submission: K152808
- Applicant / Sponsor: U&U Medical Technology Co, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2016-03-25
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.