Cleared Traditional

K941919 - OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM

K941919 is an FDA 510(k) clearance for OKTAS ENDOSCOPY VIDEO CAMERA 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 58-day FDA review.

K941919 · Oktas · Gastroenterology & Urology device
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Jun 1994
Decision
58d
Days
Class 2
Risk

K941919 is an FDA 510(k) clearance for the OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Oktas (Ashland, US). The FDA issued a Cleared decision on June 17, 1994 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oktas devices

FDA 510(k) Submission Details - K941919

510(k) Number K941919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1994
Decision Date June 17, 1994
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
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 K941919.
KSEA REVERSE VIDEO
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
COLOR VIDEO CAMERA
K911485 · United States Endoscopy Group, Inc. · Aug 1991