Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

K-Number: K202661 · 2020-12-08

ApplicantOlympus Medical Systems Corp.
Decision Date2020-12-08
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Evis Exera III Duodenovideoscope Olympus TJF-Q190V is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2020-12-08 under approval number K202661. 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?

Evis Exera III Duodenovideoscope Olympus TJF-Q190V is a medical device that received FDA 510(k) clearance on 2020-12-08. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K202661.

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

Evis Exera III Duodenovideoscope Olympus TJF-Q190V received FDA 510(k) clearance on 2020-12-08, under approval number K202661.

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

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

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

The FDA product code for Evis Exera III Duodenovideoscope Olympus 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

View all 77 devices →

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.

↑