Cleared Traditional

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

K202661 · Olympus Medical Systems Corp. · General Hospital
Dec 2020
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K202661 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 December 8, 2020, 85 days after receiving the submission on September 14, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K202661 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2020
Decision Date December 08, 2020
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
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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