Cleared Traditional

K014036 - MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K014036 · Medtrade Products , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
69d
Days
Class 1
Risk

K014036 is an FDA 510(k) clearance for the MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SI.... Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on February 14, 2002 after a review of 69 days - a notably fast clearance cycle.

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: 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 Medtrade Products , Ltd. devices

Submission Details

510(k) Number K014036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2001
Decision Date February 14, 2002
Days to Decision 69 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
45d faster than avg
Panel avg: 114d · This submission: 69d
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.