Cleared Traditional

K042076 - FUJINON G5 DUODENSCOPES (FDA 510(k) Clearance)

Also includes:
G5 DUODENOSCOPES, ED-450XT5, ED-250XT5

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

K042076 · Fujinon, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
108d
Days
Class 2
Risk

K042076 is an FDA 510(k) clearance for the FUJINON G5 DUODENSCOPES. Classified as Duodenoscope And Accessories, Flexible/rigid (product code FDT), Class II - Special Controls.

Submitted by Fujinon, Inc. (Huntington, US). The FDA issued a Cleared decision on November 18, 2004 after a review of 108 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 Fujinon, Inc. devices

Submission Details

510(k) Number K042076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2004
Decision Date November 18, 2004
Days to Decision 108 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 130d · This submission: 108d
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 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 K042076.
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