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FDA 510(k)

TISSUE SAMPLING NEEDLE

K-Number: K103694 · 2011-07-27

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2011-07-27
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TISSUE SAMPLING NEEDLE 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 2011-07-27 under 510(k) number K103694. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUE SAMPLING NEEDLE?

TISSUE SAMPLING NEEDLE is a medical device that received FDA 510(k) clearance on 2011-07-27. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K103694.

When did TISSUE SAMPLING NEEDLE receive FDA 510(k) clearance?

TISSUE SAMPLING NEEDLE received FDA 510(k) clearance on 2011-07-27, under 510(k) number K103694.

Who is the listed applicant for TISSUE SAMPLING NEEDLE?

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 TISSUE SAMPLING NEEDLE?

The FDA product code for TISSUE SAMPLING NEEDLE is FCG.

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Related Devices (Code: FCG)

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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