Clearance Summary
OneTouch Via On-Demand Insulin Delivery System received FDA 510(k) clearance under submission number K163357, sponsored by Lifescan Europe, A Division of Cilag GmbH. 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 2017-06-07.
- Submission: K163357
- Applicant / Sponsor: Lifescan Europe, A Division of Cilag GmbH
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2017-06-07
Classification & Regulation
This clearance is catalogued under FDA product code OPP and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.