Cleared Traditional

K934092 - CAMERA

K934092 is an FDA 510(k) clearance for CAMERA, manufactured by Envision Medical Corp.. The device is a Class 1 General & Plastic Surgery device with product code FWB cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K934092 · Envision Medical Corp. · General & Plastic Surgery device
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Jan 1994
Decision
137d
Days
Class 1
Risk

K934092 is an FDA 510(k) clearance for the CAMERA, SURGICAL AND ACCESSORIES. Classified as Camera, Television, Surgical, Without Audio (product code FWB), Class I - General Controls.

Submitted by Envision Medical Corp. (Goleta, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 137 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 Envision Medical Corp. devices

FDA 510(k) Submission Details - K934092

510(k) Number K934092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1993
Decision Date January 07, 1994
Days to Decision 137 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
22d slower than avg
Panel avg: 115d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

FWB Device Classification - Class 1, General Controls

Product Code FWB Camera, Television, Surgical, 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.