Cleared Traditional

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

K220587 · Olympus Medical Systems Corp. · Gastroenterology & Urology
May 2022
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K220587 is an FDA 510(k) clearance for the Evis Exera III Duodenovideoscope Olympus TJF-Q190V, a Duodenoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FDT), submitted by Olympus Medical Systems Corp. (Hachiochi-Shi, JP). The FDA issued a Cleared decision on May 11, 2022, 71 days after receiving the submission on March 1, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K220587 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2022
Decision Date May 11, 2022
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FDT — Duodenoscope And Accessories, Flexible/rigid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

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