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FDA 510(k)

FUJIFILM Duodenoscope Model

K-Number: K182051 · 2018-10-02

ApplicantFujifilm Corporation
Decision Date2018-10-02
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Duodenoscope Model is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2018-10-02 under approval number K182051. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Duodenoscope Model?

FUJIFILM Duodenoscope Model is a medical device that received FDA 510(k) clearance on 2018-10-02. It is manufactured by Fujifilm Corporation. The 510(k) number is K182051.

When was FUJIFILM Duodenoscope Model approved by the FDA?

FUJIFILM Duodenoscope Model received FDA 510(k) clearance on 2018-10-02, under approval number K182051.

What company makes FUJIFILM Duodenoscope Model?

FUJIFILM Duodenoscope Model is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Duodenoscope Model?

The FDA product code for FUJIFILM Duodenoscope Model is FDT.

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Related Devices (Code: FDT)

K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180VOlympus Medical Systems Corp. K163614PENTAX Medical ED34-i10T, Video DuodenoscopePentax Medical K152257Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc. K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopePentax of America, Inc. K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical K193202EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation

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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