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FDA 510(k)

OPTICAL INTEGRITY GENERAL SHAPED FIBER

K-Number: K022338 · 2002-10-16

ApplicantOptical Integrity, Inc.
Decision Date2002-10-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTICAL INTEGRITY GENERAL SHAPED FIBER 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 2002-10-16 under 510(k) number K022338. 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 GENERAL SHAPED FIBER?

OPTICAL INTEGRITY GENERAL SHAPED FIBER is a medical device that received FDA 510(k) clearance on 2002-10-16. The listed applicant is Optical Integrity, Inc.. The 510(k) number is K022338.

When did OPTICAL INTEGRITY GENERAL SHAPED FIBER receive FDA 510(k) clearance?

OPTICAL INTEGRITY GENERAL SHAPED FIBER received FDA 510(k) clearance on 2002-10-16, under 510(k) number K022338.

Who is the listed applicant for OPTICAL INTEGRITY GENERAL SHAPED FIBER?

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 GENERAL SHAPED FIBER?

The FDA product code for OPTICAL INTEGRITY GENERAL SHAPED FIBER 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.

K100194OPTICAL INTEGRITY LASERGUARD FIBERS

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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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