Cleared Traditional

K944254 - OKTAS STEREO VIEWING SYSTEM

K944254 is an FDA 510(k) clearance for OKTAS STEREO VIEWING SYSTEM, manufactured by Oktas. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K944254 · Oktas · Gastroenterology & Urology device
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Nov 1994
Decision
91d
Days
Class 2
Risk

K944254 is an FDA 510(k) clearance for the OKTAS STEREO VIEWING SYSTEM. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Oktas (Westborough, US). The FDA issued a Cleared decision on November 30, 1994 after a review of 91 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 Oktas devices

FDA 510(k) Submission Details - K944254

510(k) Number K944254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1994
Decision Date November 30, 1994
Days to Decision 91 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
39d faster than avg
Panel avg: 130d · This submission: 91d
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
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K944254.
EVIS 140 SYSTEM
K954451 · Olympus America, Inc. · Mar 1996
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K952482 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
K944759 · Fujinon, Inc. · Apr 1995
OLYMPUS SWITCHING UNIT MODEL SU-1
K944081 · Olympus America, Inc. · Nov 1994
FUJINON VIDEO LAPAROSCOPE -- MODIFIED
K932312 · Fujinon, Inc. · Feb 1994
EPM-3300 VIDEO PROCESSOR
K934918 · Pentax Precision Instrument Corp. · Feb 1994