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FDA 510(k)

IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1

K-Number: K060905 · 2006-05-31

ApplicantIridex Corp
Decision Date2006-05-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corp. It received FDA 510(k) clearance on 2006-05-31 under 510(k) number K060905. 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 IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1?

IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 is a medical device that received FDA 510(k) clearance on 2006-05-31. The listed applicant is Iridex Corp. The 510(k) number is K060905.

When did IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 receive FDA 510(k) clearance?

IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 received FDA 510(k) clearance on 2006-05-31, under 510(k) number K060905.

Who is the listed applicant for IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1?

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 IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1?

The FDA product code for IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 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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