Cleared Traditional

K014036 - MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL

K014036 is an FDA 510(k) clearance for MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, manufactured by Medtrade Products , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

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

FDA 510(k) Submission Details - K014036

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
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

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.

Regulatory Peers - MDA Elastomer, Silicone, For Scar Management

All 11
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K014036.
CURAD SCAR THERAPY
K024057 · Beiersdorf, Inc. · Jun 2003
NEOSPORIN SCAR SOLUTION
K024160 · Warner-Lambert Co. · Mar 2003
GELZONE
K013732 · Implantech Associates, Inc. · Feb 2002
CONFORM SHEETING, MODEL IGEL
K012419 · Implantech Associates, Inc. · Oct 2001
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · Smith & Nephew, Inc. · Jul 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · Smith & Nephew, Inc. · Jul 1999