Cleared Traditional

K003325 - KSI'S NEW CAMERA ARCHITECTURE (NCA) VID...

K003325 is an FDA 510(k) clearance for KSI'S NEW CAMERA ARCHITECTURE (NCA) VID..., manufactured by Karl Storz Imaging, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K003325 · Karl Storz Imaging, Inc. · Gastroenterology & Urology device
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Apr 2001
Decision
185d
Days
Class 2
Risk

K003325 is an FDA 510(k) clearance for the KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Karl Storz Imaging, Inc. (Goleta, US). The FDA issued a Cleared decision on April 27, 2001 after a review of 185 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 Imaging, Inc. devices

FDA 510(k) Submission Details - K003325

510(k) Number K003325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2000
Decision Date April 27, 2001
Days to Decision 185 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 130d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

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 58
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