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FDA 510(k)

FUJIFILM Duodenoscope Model ED-580XT

K-Number: K191747 · 2019-09-27

ApplicantFujifilm Corporation
Decision Date2019-09-27
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Duodenoscope Model ED-580XT is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K191747. 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 ED-580XT?

FUJIFILM Duodenoscope Model ED-580XT is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Fujifilm Corporation. The 510(k) number is K191747.

When did FUJIFILM Duodenoscope Model ED-580XT receive FDA 510(k) clearance?

FUJIFILM Duodenoscope Model ED-580XT received FDA 510(k) clearance on 2019-09-27, under 510(k) number K191747.

Who is the listed applicant for FUJIFILM Duodenoscope Model ED-580XT?

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

What is the FDA product code for FUJIFILM Duodenoscope Model ED-580XT?

The FDA product code for FUJIFILM Duodenoscope Model ED-580XT is FDT.

Other records listing Fujifilm Corporation as applicant

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Related Devices (Code: FDT)

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.

K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000Fujifilm CorporationK253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S

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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