Cleared Traditional

K944759 - 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM

K944759 is an FDA 510(k) clearance for 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM, manufactured by Fujinon, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K944759 · Fujinon, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
196d
Days
Class 2
Risk

K944759 is an FDA 510(k) clearance for the 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Fujinon, Inc. (Wayne, US). The FDA issued a Cleared decision on April 11, 1995 after a review of 196 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.

FDA 510(k) Submission Details - K944759

510(k) Number K944759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1994
Decision Date April 11, 1995
Days to Decision 196 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 131d · This submission: 196d
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 100
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K944759.
KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS
K950974 · Karl Storz Imaging, Inc. · May 1995
KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS
K950975 · Karl Storz Imaging, Inc. · May 1995
SERIES 400 GASTROENTEROLOGY SYSTEM
K944620 · Marks & Murase · Apr 1995
OKTAS STEREO VIEWING SYSTEM
K944254 · Oktas · Nov 1994
OLYMPUS SWITCHING UNIT MODEL SU-1
K944081 · Olympus America, Inc. · Nov 1994
KARL STORZ ENDOVISION UROCAM/HYSTEROCAM
K940283 · Medical Concepts, Inc. · Sep 1994
K944759 · 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
Download PDF Fujinon, Inc.