Cleared Traditional

K250701 - Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250701 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
90d
Days
Class 2
Risk

K250701 is an FDA 510(k) clearance for the Evis Exera III Duodenovideoscope Olympus TJF-Q190V (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 June 5, 2025 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K250701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2025
Decision Date June 05, 2025
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Surgical Technologies of the Americas
Darlene Hull

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 34
Devices cleared under the same product code (FDT) and FDA review panel - the closest regulatory comparables to K250701.
FUJIFILM Endoscope Model ED-S100TP
K251861 · Fujifilm Corporation · Mar 2026
Single Use Distal Cover MAJ-2315 (MAJ-2315)
K253646 · Olympus Medical Systems Corp. · Feb 2026
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
K251867 · Olympus Medical Systems Corp. · Sep 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
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K220587 · Olympus Medical Systems Corp. · May 2022