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FDA 510(k)

CONCENTRIC BALLOON GOOGLE

K-Number: K112698 · 2012-05-18

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2012-05-18
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONCENTRIC BALLOON GOOGLE is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2012-05-18 under 510(k) number K112698. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCENTRIC BALLOON GOOGLE?

CONCENTRIC BALLOON GOOGLE is a medical device that received FDA 510(k) clearance on 2012-05-18. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K112698.

When did CONCENTRIC BALLOON GOOGLE receive FDA 510(k) clearance?

CONCENTRIC BALLOON GOOGLE received FDA 510(k) clearance on 2012-05-18, under 510(k) number K112698.

Who is the listed applicant for CONCENTRIC BALLOON GOOGLE?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONCENTRIC BALLOON GOOGLE?

The FDA product code for CONCENTRIC BALLOON GOOGLE is ODC.

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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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