Cleared Traditional

K894397 - WELCON LIGHT HANDLE

K894397 is the FDA 510(k) clearance for WELCON LIGHT HANDLE by Welcon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTA) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K894397 · Welcon, Inc. · General & Plastic Surgery device
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Aug 1989
Decision
21d
Days
Class 2
Risk

K894397 is an FDA 510(k) clearance for the WELCON LIGHT HANDLE. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Welcon, Inc. (Providence, US). The FDA issued a Cleared decision on August 10, 1989 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 Welcon, Inc. devices

Submission Details

510(k) Number K894397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date August 10, 1989
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTA Light, Surgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTA Light, Surgical, Accessories

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