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FDA 510(k)

V30 system, V-Form Handpiece BC Medium applicator

K-Number: K162363 · 2016-11-18

ApplicantViora , Ltd.
Decision Date2016-11-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

V30 system, V-Form Handpiece BC Medium applicator is a medical device manufactured by Viora , Ltd.. It received FDA 510(k) clearance on 2016-11-18 under approval number K162363. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V30 system, V-Form Handpiece BC Medium applicator?

V30 system, V-Form Handpiece BC Medium applicator is a medical device that received FDA 510(k) clearance on 2016-11-18. It is manufactured by Viora , Ltd.. The 510(k) number is K162363.

When was V30 system, V-Form Handpiece BC Medium applicator approved by the FDA?

V30 system, V-Form Handpiece BC Medium applicator received FDA 510(k) clearance on 2016-11-18, under approval number K162363.

What company makes V30 system, V-Form Handpiece BC Medium applicator?

V30 system, V-Form Handpiece BC Medium applicator is manufactured by Viora , Ltd..

What is the FDA product code for V30 system, V-Form Handpiece BC Medium applicator?

The FDA product code for V30 system, V-Form Handpiece BC Medium applicator is GEX. This falls under the Gastroenterology category.

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Other Devices by Viora , Ltd.

K152611V20 system K202247V30 system, V20 system, V10 system, V-VR Hand piece K201064V30 System, V20 System, V10 System, V-FR Handpiece K200468V30 system, V20 system, V10 system, V-FC Handpiece

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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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