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FDA 510(k)

OmniGuide BeamPath OTO-U Fiber

K-Number: K203241 · 2021-01-14

ApplicantOmniguide, Inc.
Decision Date2021-01-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OmniGuide BeamPath OTO-U Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Omniguide, Inc.. It received FDA 510(k) clearance on 2021-01-14 under 510(k) number K203241. 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 OTO-U Fiber?

OmniGuide BeamPath OTO-U Fiber is a medical device that received FDA 510(k) clearance on 2021-01-14. The listed applicant is Omniguide, Inc.. The 510(k) number is K203241.

When did OmniGuide BeamPath OTO-U Fiber receive FDA 510(k) clearance?

OmniGuide BeamPath OTO-U Fiber received FDA 510(k) clearance on 2021-01-14, under 510(k) number K203241.

Who is the listed applicant for OmniGuide BeamPath OTO-U Fiber?

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 OTO-U Fiber?

The FDA product code for OmniGuide BeamPath OTO-U Fiber is GEX. This falls under the Gastroenterology category.

Other records listing Omniguide, Inc. as applicant

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Related Devices (Code: GEX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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