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FDA 510(k)

IRIS G-PROBE

K-Number: K915236 · 1994-07-28

ApplicantIriderm Div.
Decision Date1994-07-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IRIS G-PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Iriderm Div.. It received FDA 510(k) clearance on 1994-07-28 under 510(k) number K915236. 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 IRIS G-PROBE?

IRIS G-PROBE is a medical device that received FDA 510(k) clearance on 1994-07-28. The listed applicant is Iriderm Div.. The 510(k) number is K915236.

When did IRIS G-PROBE receive FDA 510(k) clearance?

IRIS G-PROBE received FDA 510(k) clearance on 1994-07-28, under 510(k) number K915236.

Who is the listed applicant for IRIS G-PROBE?

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

What is the FDA product code for IRIS G-PROBE?

The FDA product code for IRIS G-PROBE 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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