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FDA 510(k)

FOREIGN BODY HOOD

K-Number: K130148 · 2013-08-07

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2013-08-07
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOREIGN BODY HOOD 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 2013-08-07 under 510(k) number K130148. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOREIGN BODY HOOD?

FOREIGN BODY HOOD is a medical device that received FDA 510(k) clearance on 2013-08-07. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K130148.

When did FOREIGN BODY HOOD receive FDA 510(k) clearance?

FOREIGN BODY HOOD received FDA 510(k) clearance on 2013-08-07, under 510(k) number K130148.

Who is the listed applicant for FOREIGN BODY HOOD?

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 FOREIGN BODY HOOD?

The FDA product code for FOREIGN BODY HOOD is FDS.

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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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