Cleared Traditional

K024160 - NEOSPORIN SCAR SOLUTION

K024160 is an FDA 510(k) clearance for NEOSPORIN SCAR SOLUTION, manufactured by Warner-Lambert Co.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K024160 · Warner-Lambert Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
90d
Days
Class 1
Risk

K024160 is an FDA 510(k) clearance for the NEOSPORIN SCAR SOLUTION. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on March 17, 2003 after a review of 90 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 Warner-Lambert Co. devices

FDA 510(k) Submission Details - K024160

510(k) Number K024160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2002
Decision Date March 17, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 54
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K024160.
CORELEADER SCAR-DIMMER
K111733 · Coreleader Biotech Co., Ltd. · Sep 2011
NEWGEL AND NEWGEL PLUS E
K041704 · Newmedical Technology, Inc. · Oct 2005
CURAD SCAR THERAPY
K024057 · Beiersdorf, Inc. · Jun 2003
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.
K014036 · Medtrade Products , Ltd. · Feb 2002
GELZONE
K013732 · Implantech Associates, Inc. · Feb 2002
CONFORM SHEETING, MODEL IGEL
K012419 · Implantech Associates, Inc. · Oct 2001