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FDA 510(k)

DISPOSABLE FIBER OPTIC DELIVERY SYSTEM

K-Number: K904911 · 1991-01-25

ApplicantFiber Delivery Concepts, Inc.
Decision Date1991-01-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE FIBER OPTIC DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fiber Delivery Concepts, Inc.. It received FDA 510(k) clearance on 1991-01-25 under 510(k) number K904911. 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 DISPOSABLE FIBER OPTIC DELIVERY SYSTEM?

DISPOSABLE FIBER OPTIC DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-01-25. The listed applicant is Fiber Delivery Concepts, Inc.. The 510(k) number is K904911.

When did DISPOSABLE FIBER OPTIC DELIVERY SYSTEM receive FDA 510(k) clearance?

DISPOSABLE FIBER OPTIC DELIVERY SYSTEM received FDA 510(k) clearance on 1991-01-25, under 510(k) number K904911.

Who is the listed applicant for DISPOSABLE FIBER OPTIC DELIVERY SYSTEM?

The FDA 510(k) record lists Fiber Delivery Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE FIBER OPTIC DELIVERY SYSTEM?

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Fiber Delivery Concepts, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K904420DISPOSABLE FIBER OPTIC DELIVERY SYSTEMK904407DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURGK896939DISPOSABLE FIBER OPTIC DELIVERY SYSTEM FOR ND:YAG

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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