Cleared Traditional

K984213 - NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS

K984213 is an FDA 510(k) clearance for NEARLY ME RETOUCH SILICONE SCAR REDUCTI..., manufactured by Capital Marketing Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K984213 · Capital Marketing Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
141d
Days
Class 1
Risk

K984213 is an FDA 510(k) clearance for the NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Capital Marketing Technologies, Inc. (Waco, US). The FDA issued a Cleared decision on April 14, 1999 after a review of 141 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 Capital Marketing Technologies, Inc. devices

FDA 510(k) Submission Details - K984213

510(k) Number K984213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1998
Decision Date April 14, 1999
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
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 41
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K984213.
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · Smith & Nephew, Inc. · Jul 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · Smith & Nephew, Inc. · Jul 1999
AVOGEL
K981353 · Avocet Polymer Technologies, Inc. · Jun 1999
SCAREASE & SCAREASE ADHESIVE GEL
K984115 · Scarease, Inc. · Feb 1999
SILON SCAR STRIPS
K982036 · Bio Med Sciences, Inc. · Aug 1998
KELOCATE SHEETING
K982051 · Allied Biomedical Corp. · Aug 1998