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FDA 510(k)

FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES

K-Number: K022228 · 2002-10-08

ApplicantIridex Corp
Decision Date2002-10-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corp. It received FDA 510(k) clearance on 2002-10-08 under 510(k) number K022228. 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 FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES?

FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES is a medical device that received FDA 510(k) clearance on 2002-10-08. The listed applicant is Iridex Corp. The 510(k) number is K022228.

When did FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES receive FDA 510(k) clearance?

FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES received FDA 510(k) clearance on 2002-10-08, under 510(k) number K022228.

Who is the listed applicant for FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES?

The FDA 510(k) record lists Iridex Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES?

The FDA product code for FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES 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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