Cleared Traditional

K071254 - SMALL INTESTINAL VIDEOSCOPE SYSTEM

K071254 is the FDA 510(k) clearance for SMALL INTESTINAL VIDEOSCOPE SYSTEM by Olympus Medical Systems Corporation. It is a Class 2 Gastroenterology & Urology device (product code FDA) cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K071254 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
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Mar 2008
Decision
326d
Days
Class 2
Risk

K071254 is an FDA 510(k) clearance for the SMALL INTESTINAL VIDEOSCOPE SYSTEM. Classified as Enteroscope And Accessories (product code FDA), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on March 25, 2008 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K071254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2007
Decision Date March 25, 2008
Days to Decision 326 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
196d slower than avg
Panel avg: 130d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (FDA) and FDA review panel - the closest regulatory comparables to K071254.
FUJIFILM Double Balloon Endoscope EI580BT
K183032 · Fujifilm Corporation · Jun 2019
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
K183683 · Fujifilm Corporation · Feb 2019
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
K143556 · Fujifilm Medical Systems U.S.A, Inc. · Aug 2015
SIF-SW
K904800 · Olympus Corp. · Mar 1991
ENTEROSCOPE
K840722 · Trimedyne, Inc. · Jun 1984