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FDA 510(k)

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)

K-Number: K250701 · 2025-06-05

ApplicantOlympus Medical Systems Corp.
Decision Date2025-06-05
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2025-06-05 under approval number K250701. 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 Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)?

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) is a medical device that received FDA 510(k) clearance on 2025-06-05. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K250701.

When was Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) approved by the FDA?

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) received FDA 510(k) clearance on 2025-06-05, under approval number K250701.

What company makes Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)?

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)?

The FDA product code for Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) is FDT.

Other Devices by Olympus Medical Systems Corp.

K153773Disposal Lens Cleaning Sheath K160098Single Use Aspiration Needle NA-U401SX K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 K151743THUNDERBEAT Open Fine Jaw K153625Single Use Injector NM600/610 K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

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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. K182051FUJIFILM Duodenoscope ModelFujifilm Corporation K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopePentax of America, Inc. K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical

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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