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FDA 510(k)

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

K-Number: K143153 · 2016-01-15

ApplicantOlympus Medical Systems Corp.
Decision Date2016-01-15
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2016-01-15 under approval number K143153. 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 II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V?

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is a medical device that received FDA 510(k) clearance on 2016-01-15. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K143153.

When was EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V approved by the FDA?

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V received FDA 510(k) clearance on 2016-01-15, under approval number K143153.

What company makes EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V?

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V?

The FDA product code for EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is 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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