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FDA 510(k)

MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100

K-Number: K050165 · 2005-04-19

ApplicantCyden Limited
Decision Date2005-04-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2005-04-19 under 510(k) number K050165. 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 MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100?

MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 is a medical device that received FDA 510(k) clearance on 2005-04-19. The listed applicant is Cyden Limited. The 510(k) number is K050165.

When did MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 receive FDA 510(k) clearance?

MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 received FDA 510(k) clearance on 2005-04-19, under 510(k) number K050165.

Who is the listed applicant for MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100?

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

What is the FDA product code for MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100?

The FDA product code for MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 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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