Cleared Traditional

K951519 - WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC...

K951519 is an FDA 510(k) clearance for WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC..., manufactured by Wells Johnson Co.. The device is a Class 1 General & Plastic Surgery device with product code FWL cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K951519 · Wells Johnson Co. · General & Plastic Surgery device
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Jun 1995
Decision
72d
Days
Class 1
Risk

K951519 is an FDA 510(k) clearance for the WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT. Classified as Camera, Cine, Endoscopic, Without Audio (product code FWL), Class I - General Controls.

Submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on June 14, 1995 after a review of 72 days - a notably fast clearance 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: 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 Wells Johnson Co. devices

FDA 510(k) Submission Details - K951519

510(k) Number K951519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date June 14, 1995
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

FWL Device Classification - Class 1, General Controls

Product Code FWL Camera, Cine, 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.