Cleared Traditional

K003113 - KSEA SCB-RUI SCO

K003113 is the FDA 510(k) clearance for KSEA SCB-RUI SCO 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 174-day FDA review.

K003113 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2001
Decision
174d
Days
Class 2
Risk

K003113 is an FDA 510(k) clearance for the KSEA SCB-RUI SCO. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on March 27, 2001 after a review of 174 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 K003113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2000
Decision Date March 27, 2001
Days to Decision 174 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
44d slower than avg
Panel avg: 130d · This submission: 174d
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 53
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K003113.
KSEA OPSERVER LAP
K031895 · KARL STORZ Endoscopy-America, Inc. · Sep 2003
1-CCD ENDOCAM 5520 SYSTEM
K023659 · Richard Wolf Medical Instruments Corp. · Jan 2003
HILL-ROM PRIMAVIEW MONITOR SYSTEM
K013709 · Hill-Rom, Inc. · Nov 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
K003710 · Smith & Nephew, Inc. · Feb 2001
KSEA SCB-RUI
K994348 · KARL STORZ Endoscopy-America, Inc. · Mar 2000
KSEA SCBCOM
K992469 · Karl Storz Endoscopy · Oct 1999