Cleared Traditional

K926166 - COAST VIDEO ENDOSCOPIC IMAGING SYSTEM

K926166 is an FDA 510(k) clearance for COAST VIDEO ENDOSCOPIC IMAGING SYSTEM, manufactured by Optik. The device is a Class 1 General & Plastic Surgery device with product code FWF cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K926166 · Optik · General & Plastic Surgery device
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Jun 1993
Decision
175d
Days
Class 1
Risk

K926166 is an FDA 510(k) clearance for the COAST VIDEO ENDOSCOPIC IMAGING SYSTEM. Classified as Camera, Television, Endoscopic, Without Audio (product code FWF), Class I - General Controls.

Submitted by Optik (Odenton, US). The FDA issued a Cleared decision on June 1, 1993 after a review of 175 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4160 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Optik devices

FDA 510(k) Submission Details - K926166

510(k) Number K926166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1992
Decision Date June 01, 1993
Days to Decision 175 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

FWF Device Classification - Class 1, General Controls

Product Code FWF Camera, Television, Endoscopic, Without Audio
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FWF Camera, Television, Endoscopic, Without Audio

All 17
Devices cleared under the same product code (FWF) and FDA review panel - the closest regulatory comparables to K926166.
FUJINON VIDEO LAPAROSCOPE, MODIFIED
K930297 · Fujinon, Inc. · Mar 1994
SURGICAL VIDEO CAMERA AND ACCESSORIES
K934682 · Medical Dynamics, Inc. · Feb 1994
ENDOSCOPIC VIDEO CAMERA
K932628 · Stephen Chakoff, Inc. · Oct 1993
VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10
K930053 · Medical Devices, Inc. · May 1993
INTEGRATED VISUALIZATION SYSTEM
K925108 · Neuro Navigational Corp. · Jan 1993
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS
K911163 · Imagyn Medical, Inc. · Jun 1991