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FDA 510(k)

OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM

K-Number: K062423 · 2006-09-21

ApplicantOmniguide, Inc.
Decision Date2006-09-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Omniguide, Inc.. It received FDA 510(k) clearance on 2006-09-21 under 510(k) number K062423. 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 OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM?

OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-21. The listed applicant is Omniguide, Inc.. The 510(k) number is K062423.

When did OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM receive FDA 510(k) clearance?

OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM received FDA 510(k) clearance on 2006-09-21, under 510(k) number K062423.

Who is the listed applicant for OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM?

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 OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM?

The FDA product code for OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM 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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