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FDA 510(k)

OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY

K-Number: K081939 · 2008-08-12

ApplicantOmniguide, Inc.
Decision Date2008-08-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Omniguide, Inc.. It received FDA 510(k) clearance on 2008-08-12 under 510(k) number K081939. 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 FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY?

OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY is a medical device that received FDA 510(k) clearance on 2008-08-12. The listed applicant is Omniguide, Inc.. The 510(k) number is K081939.

When did OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY receive FDA 510(k) clearance?

OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY received FDA 510(k) clearance on 2008-08-12, under 510(k) number K081939.

Who is the listed applicant for OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY?

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 FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY?

The FDA product code for OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY 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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