Cleared Traditional

K934883 - 3D VIDEO SYSTEM (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K934883 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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Mar 1994
Decision
146d
Days
Class 1
Risk

K934883 is an FDA 510(k) clearance for the 3D VIDEO SYSTEM. Classified as Camera, Television, Endoscopic, With Audio (product code FWG), Class I - General Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 146 days - within the typical 510(k) review window.

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 Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K934883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1993
Decision Date March 07, 1994
Days to Decision 146 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
32d slower than avg
Panel avg: 114d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FWG Camera, Television, Endoscopic, With 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.