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FDA 510(k)

HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00

K-Number: K061909 · 2006-07-19

ApplicantOmniguide, Inc.
Decision Date2006-07-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 is the device name listed in this FDA 510(k) record. The listed applicant is Omniguide, Inc.. It received FDA 510(k) clearance on 2006-07-19 under 510(k) number K061909. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00?

HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 is a medical device that received FDA 510(k) clearance on 2006-07-19. The listed applicant is Omniguide, Inc.. The 510(k) number is K061909.

When did HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 receive FDA 510(k) clearance?

HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 received FDA 510(k) clearance on 2006-07-19, under 510(k) number K061909.

Who is the listed applicant for HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00?

The FDA 510(k) record lists Omniguide, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00?

The FDA product code for HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 is GEX. This falls under the Gastroenterology category.

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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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