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FDA 510(k)

MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP

K-Number: K073313 · 2008-01-02

ApplicantOmniguide, Inc.
Decision Date2008-01-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP is the device name listed in this FDA 510(k) record. The listed applicant is Omniguide, Inc.. It received FDA 510(k) clearance on 2008-01-02 under 510(k) number K073313. 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 MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP?

MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP is a medical device that received FDA 510(k) clearance on 2008-01-02. The listed applicant is Omniguide, Inc.. The 510(k) number is K073313.

When did MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP receive FDA 510(k) clearance?

MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP received FDA 510(k) clearance on 2008-01-02, under 510(k) number K073313.

Who is the listed applicant for MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP?

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 MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP?

The FDA product code for MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP is GEX. This falls under the Gastroenterology category.

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Other records listing Omniguide, Inc. as applicant

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Related Devices (Code: GEX)

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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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