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FDA 510(k)

D'AMICO\PEYMAN FLUTED ENDOPROBE

K-Number: K933211 · 1994-04-19

ApplicantIriderm Div.
Decision Date1994-04-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

D'AMICO\PEYMAN FLUTED ENDOPROBE is the device name listed in this FDA 510(k) record. The listed applicant is Iriderm Div.. It received FDA 510(k) clearance on 1994-04-19 under 510(k) number K933211. 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 D'AMICO\PEYMAN FLUTED ENDOPROBE?

D'AMICO\PEYMAN FLUTED ENDOPROBE is a medical device that received FDA 510(k) clearance on 1994-04-19. The listed applicant is Iriderm Div.. The 510(k) number is K933211.

When did D'AMICO\PEYMAN FLUTED ENDOPROBE receive FDA 510(k) clearance?

D'AMICO\PEYMAN FLUTED ENDOPROBE received FDA 510(k) clearance on 1994-04-19, under 510(k) number K933211.

Who is the listed applicant for D'AMICO\PEYMAN FLUTED ENDOPROBE?

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 D'AMICO\PEYMAN FLUTED ENDOPROBE?

The FDA product code for D'AMICO\PEYMAN FLUTED ENDOPROBE 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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