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FDA 510(k)

OneTouch Via On-Demand Insulin Delivery System

K-Number: K163357 · 2017-06-07

ApplicantLifescan Europe, A Division of Cilag GmbH
Decision Date2017-06-07
Product CodeOPP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OneTouch Via On-Demand Insulin Delivery System is a medical device manufactured by Lifescan Europe, A Division of Cilag GmbH. It received FDA 510(k) clearance on 2017-06-07 under approval number K163357. The device is classified under product code OPP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OneTouch Via On-Demand Insulin Delivery System?

OneTouch Via On-Demand Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2017-06-07. It is manufactured by Lifescan Europe, A Division of Cilag GmbH. The 510(k) number is K163357.

When was OneTouch Via On-Demand Insulin Delivery System approved by the FDA?

OneTouch Via On-Demand Insulin Delivery System received FDA 510(k) clearance on 2017-06-07, under approval number K163357.

What company makes OneTouch Via On-Demand Insulin Delivery System?

OneTouch Via On-Demand Insulin Delivery System is manufactured by Lifescan Europe, A Division of Cilag GmbH.

What is the FDA product code for OneTouch Via On-Demand Insulin Delivery System?

The FDA product code for OneTouch Via On-Demand Insulin Delivery System is OPP.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING

Related PubMed Literature

PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 37873612 A European regulatory pathway for Tidepool loop following clearance in the United States? Diabetic medicine : a journal of the British Diabetic Association (2024)

Related Devices (Code: OPP)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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