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FDA 510(k)

FT FIBER OPTIC DELIVERY SYSTEMS

K-Number: K050738 · 2005-06-02

ApplicantFibertech GmbH
Decision Date2005-06-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FT FIBER OPTIC DELIVERY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Fibertech GmbH. It received FDA 510(k) clearance on 2005-06-02 under 510(k) number K050738. 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 FT FIBER OPTIC DELIVERY SYSTEMS?

FT FIBER OPTIC DELIVERY SYSTEMS is a medical device that received FDA 510(k) clearance on 2005-06-02. The listed applicant is Fibertech GmbH. The 510(k) number is K050738.

When did FT FIBER OPTIC DELIVERY SYSTEMS receive FDA 510(k) clearance?

FT FIBER OPTIC DELIVERY SYSTEMS received FDA 510(k) clearance on 2005-06-02, under 510(k) number K050738.

Who is the listed applicant for FT FIBER OPTIC DELIVERY SYSTEMS?

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

What is the FDA product code for FT FIBER OPTIC DELIVERY SYSTEMS?

The FDA product code for FT FIBER OPTIC DELIVERY SYSTEMS is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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