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FDA 510(k)

US ENDOSCOPY CYTOLOGY BRUSH

K-Number: K103437 · 2010-12-23

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2010-12-23
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

US ENDOSCOPY CYTOLOGY BRUSH 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 2010-12-23 under 510(k) number K103437. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the US ENDOSCOPY CYTOLOGY BRUSH?

US ENDOSCOPY CYTOLOGY BRUSH is a medical device that received FDA 510(k) clearance on 2010-12-23. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K103437.

When did US ENDOSCOPY CYTOLOGY BRUSH receive FDA 510(k) clearance?

US ENDOSCOPY CYTOLOGY BRUSH received FDA 510(k) clearance on 2010-12-23, under 510(k) number K103437.

Who is the listed applicant for US ENDOSCOPY CYTOLOGY BRUSH?

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 US ENDOSCOPY CYTOLOGY BRUSH?

The FDA product code for US ENDOSCOPY CYTOLOGY BRUSH is FDX.

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Related Devices (Code: FDX)

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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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