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FDA 510(k)

DISPOSABLE OVERTUBE

K-Number: K040836 · 2004-06-10

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2004-06-10
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE OVERTUBE 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 2004-06-10 under 510(k) number K040836. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE OVERTUBE?

DISPOSABLE OVERTUBE is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K040836.

When did DISPOSABLE OVERTUBE receive FDA 510(k) clearance?

DISPOSABLE OVERTUBE received FDA 510(k) clearance on 2004-06-10, under 510(k) number K040836.

Who is the listed applicant for DISPOSABLE OVERTUBE?

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 DISPOSABLE OVERTUBE?

The FDA product code for DISPOSABLE OVERTUBE is FED.

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Related Devices (Code: FED)

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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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