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FDA 510(k)

OPTICAL INTEGRITY LASERGUARD FIBERS

K-Number: K100194 · 2010-05-20

ApplicantOptical Integrity, Inc.
Decision Date2010-05-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTICAL INTEGRITY LASERGUARD FIBERS is the device name listed in this FDA 510(k) record. The listed applicant is Optical Integrity, Inc.. It received FDA 510(k) clearance on 2010-05-20 under 510(k) number K100194. 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 OPTICAL INTEGRITY LASERGUARD FIBERS?

OPTICAL INTEGRITY LASERGUARD FIBERS is a medical device that received FDA 510(k) clearance on 2010-05-20. The listed applicant is Optical Integrity, Inc.. The 510(k) number is K100194.

When did OPTICAL INTEGRITY LASERGUARD FIBERS receive FDA 510(k) clearance?

OPTICAL INTEGRITY LASERGUARD FIBERS received FDA 510(k) clearance on 2010-05-20, under 510(k) number K100194.

Who is the listed applicant for OPTICAL INTEGRITY LASERGUARD FIBERS?

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

What is the FDA product code for OPTICAL INTEGRITY LASERGUARD FIBERS?

The FDA product code for OPTICAL INTEGRITY LASERGUARD FIBERS is GEX. This falls under the Gastroenterology category.

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Other records listing Optical Integrity, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022338OPTICAL INTEGRITY GENERAL SHAPED FIBER

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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