Cleared Traditional

K131953 - IMAGE1 SPIES

K131953 is the FDA 510(k) clearance for IMAGE1 SPIES by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FET) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K131953 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Dec 2013
Decision
176d
Days
Class 2
Risk

K131953 is an FDA 510(k) clearance for the IMAGE1 SPIES. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 176 days - an extended review cycle.

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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K131953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date December 20, 2013
Days to Decision 176 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
46d slower than avg
Panel avg: 130d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 52
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K131953.
Processor VP-7000, Light Source BL-7000
K163675 · Fujifilm Medical System U.S.A., Inc. · Apr 2017
Image1 SPIES System
K160044 · KARL STORZ Endoscopy-America, Inc. · Feb 2016
EPX-4440HD and EPX-4400HD with FICE
K150221 · Fujifilm Medical System U.S.A., Inc. · Oct 2015
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
K130423 · Richard Wolf Medical Instruments Corp. · Apr 2013
PENTAX EPK-I5020 VIDEO PROCESSOR
K113873 · Pentax of America, Inc. · Jun 2012
IMAGE1 GI CCU MODEL 22203020-114
K111997 · KARL STORZ Endoscopy-America, Inc. · Apr 2012