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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 the device name listed in this FDA 510(k) record. The listed applicant is Viora , Ltd.. It received FDA 510(k) clearance on 2016-11-18 under 510(k) 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. The listed applicant is Viora , Ltd.. The 510(k) number is K162363.

When did V30 system, V-Form Handpiece BC Medium applicator receive FDA 510(k) clearance?

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

Who is the listed applicant for V30 system, V-Form Handpiece BC Medium applicator?

The FDA 510(k) record lists Viora , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Viora , Ltd. as applicant

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.

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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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