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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 the device name listed in this FDA 510(k) record. The listed applicant is Lifescan Europe, A Division of Cilag GmbH. It received FDA 510(k) clearance on 2017-06-07 under 510(k) 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. The listed applicant is Lifescan Europe, A Division of Cilag GmbH. The 510(k) number is K163357.

When did OneTouch Via On-Demand Insulin Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for OneTouch Via On-Demand Insulin Delivery System?

The FDA 510(k) record lists Lifescan Europe, A Division of Cilag GmbH as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05515939Evaluating the InPen in Pediatric Type 1 DiabetesACTIVE_NOT_RECRUITINGNCT07087340Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop-GenesisCOMPLETEDNCT07652528CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP TrialNOT_YET_RECRUITING

Related Devices (Code: OPP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252757CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SAK243273CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SAK233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA

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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