Cleared Traditional

K031895 - KSEA OPSERVER LAP

K031895 is the FDA 510(k) clearance for KSEA OPSERVER LAP 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 96-day FDA review.

K031895 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Sep 2003
Decision
96d
Days
Class 2
Risk

K031895 is an FDA 510(k) clearance for the KSEA OPSERVER LAP. 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 September 23, 2003 after a review of 96 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K031895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2003
Decision Date September 23, 2003
Days to Decision 96 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
34d faster than avg
Panel avg: 130d · This submission: 96d
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 K031895.
HD CAMERA HEAD OTV-S7PROH-HD-L08E
K083155 · Olympus Medical Systems Corporation · Jan 2009
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
K070716 · KARL STORZ Endoscopy-America, Inc. · May 2007
AIDA WITH DICOM AND HL7 INTERFACE
K043324 · KARL STORZ Endoscopy-America, Inc. · Apr 2005
1-CCD ENDOCAM 5520 SYSTEM
K023659 · Richard Wolf Medical Instruments Corp. · Jan 2003
HILL-ROM PRIMAVIEW MONITOR SYSTEM
K013709 · Hill-Rom, Inc. · Nov 2001
KSEA SCB-RUI SCO
K003113 · KARL STORZ Endoscopy-America, Inc. · Mar 2001