Cleared Traditional

K080403 - XTJF TYPE Q160VF1

K080403 is the FDA 510(k) clearance for XTJF TYPE Q160VF1 by Olympus Medical Systems Corporation. It is a Class 2 Gastroenterology & Urology device (product code FDT) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K080403 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
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May 2008
Decision
96d
Days
Class 2
Risk

K080403 is an FDA 510(k) clearance for the XTJF TYPE Q160VF1. Classified as Duodenoscope And Accessories, Flexible/rigid (product code FDT), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on May 20, 2008 after a review of 96 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 Corporation devices

Submission Details

510(k) Number K080403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2008
Decision Date May 20, 2008
Days to Decision 96 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
34d faster than avg
Panel avg: 130d · This submission: 96d
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 30
Devices cleared under the same product code (FDT) and FDA review panel - the closest regulatory comparables to K080403.
Fujifilm Duodenoscope Model ED-530XT
K152257 · Fujifilm Medical Systems U.S.A, Inc. · Jul 2017
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
K143153 · Olympus Medical Systems Corp. · Jan 2016
CRE BALLOON DILATATION CATHETER
K110833 · Boston Scientific Corporation · Apr 2011
OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
K980465 · Olympus America, Inc. · Apr 1998
KARL STORZ FRIMBERGER VARIOGUIDE
K962212 · KARL STORZ Endoscopy-America, Inc. · Dec 1996
ED-3410, VIDEO DUODENOSCOPE
K963056 · Pentax Precision Instrument Corp. · Oct 1996