Cleared Traditional

K220587 - Evis Exera III Duodenovideoscope Olympus TJF-Q190V

K220587 is an FDA 510(k) clearance for Evis Exera III Duodenovideoscope Olympu..., manufactured by Olympus Medical Systems Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FDT cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K220587 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
71d
Days
Class 2
Risk

K220587 is an FDA 510(k) clearance for the Evis Exera III Duodenovideoscope Olympus TJF-Q190V. Classified as Duodenoscope And Accessories, Flexible/rigid (product code FDT), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on May 11, 2022 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus Medical Systems Corp. devices

FDA 510(k) Submission Details - K220587

510(k) Number K220587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 131d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDT Device Classification - Class 2, Special Controls

Product Code FDT Duodenoscope And Accessories, Flexible/rigid
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Olympus Corporation of the Americas
Wendy Perreault

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FDT Duodenoscope And Accessories, Flexible/rigid

All 33
Devices cleared under the same product code (FDT) and FDA review panel - the closest regulatory comparables to K220587.
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
K250701 · Olympus Medical Systems Corp. · Jun 2025
PENTAX Medical Video Duodenoscope (ED34-i10T2s)
K233942 · Pentax of America, Inc. · Aug 2024
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
K233886 · Ambu A/S · Apr 2024
PENTAX Medical Video Duedenoscope ED34-i10T2
K210710 · Pentax of America, Inc. · Apr 2021
Pentax Medical Video Duodenoscope ED32-i10
K202365 · Pentax of America, Inc. · Apr 2021
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K202661 · Olympus Medical Systems Corp. · Dec 2020