Cleared Traditional

K031256 - XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE

K031256 is an FDA 510(k) clearance for XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE, manufactured by Olympus Opto-Electronics Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDA cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K031256 · Olympus Opto-Electronics Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
93d
Days
Class 2
Risk

K031256 is an FDA 510(k) clearance for the XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE. Classified as Enteroscope And Accessories (product code FDA), Class II - Special Controls.

Submitted by Olympus Opto-Electronics Co., Ltd. (Melville, US). The FDA issued a Cleared decision on July 23, 2003 after a review of 93 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 Opto-Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K031256

510(k) Number K031256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2003
Decision Date July 23, 2003
Days to Decision 93 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
37d faster than avg
Panel avg: 130d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDA Device Classification - Class 2, Special Controls

Product Code FDA Enteroscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Visualization And Perform Various Procedures Within The Small Intestine. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data 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 - FDA Enteroscope And Accessories

All 15
Devices cleared under the same product code (FDA) and FDA review panel - the closest regulatory comparables to K031256.
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
K143556 · Fujifilm Medical Systems U.S.A, Inc. · Aug 2015
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K071254 · Olympus Medical Systems Corporation · Mar 2008
FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
K040048 · Fujinon, Inc. · Jun 2004
GASTRO-INTESTINAL SYSTEM EN-410WM
K993704 · Fujinon, Inc. · Feb 2000
SIF-SW
K904800 · Olympus Corp. · Mar 1991
ENTEROSCOPE
K840722 · Trimedyne, Inc. · Jun 1984