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FDA 510(k)

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)

K-Number: K251867 · 2025-09-19

ApplicantOlympus Medical Systems Corp.
Decision Date2025-09-19
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 2025-09-19 under approval number K251867. 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 2025-09-19. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K251867.

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 2025-09-19, under approval number K251867.

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.

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Related Devices (Code: FDT)

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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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