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FDA 510(k)

EUS BALLOON

K-Number: K111028 · 2011-11-01

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2011-11-01
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EUS BALLOON 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 2011-11-01 under 510(k) number K111028. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUS BALLOON?

EUS BALLOON is a medical device that received FDA 510(k) clearance on 2011-11-01. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K111028.

When did EUS BALLOON receive FDA 510(k) clearance?

EUS BALLOON received FDA 510(k) clearance on 2011-11-01, under 510(k) number K111028.

Who is the listed applicant for EUS BALLOON?

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 EUS BALLOON?

The FDA product code for EUS BALLOON is FDF.

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Related Devices (Code: FDF)

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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