Cleared Traditional

KELO-COTE TOPICAL GEL (K002488) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K002488 · Advanced Bio-Technologies, Inc. · General & Plastic Surgery device
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Jan 2001
Decision
144d
Days
Class 1
Risk

K002488 is an FDA 510(k) clearance for the KELO-COTE TOPICAL GEL. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Advanced Bio-Technologies, Inc. (Cranage, Cheshire, GB). The FDA issued a Cleared decision on January 5, 2001 after a review of 144 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - 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 Advanced Bio-Technologies, Inc. devices

Submission Details

510(k) Number K002488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2000
Decision Date January 05, 2001
Days to Decision 144 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 115d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
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.