Cleared Traditional

K012419 - CONFORM SHEETING, MODEL IGEL

K012419 is an FDA 510(k) clearance for CONFORM SHEETING, manufactured by Implantech Associates, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K012419 · Implantech Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
86d
Days
Class 1
Risk

K012419 is an FDA 510(k) clearance for the CONFORM SHEETING, MODEL IGEL. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on October 24, 2001 after a review of 86 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 Implantech Associates, Inc. devices

FDA 510(k) Submission Details - K012419

510(k) Number K012419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2001
Decision Date October 24, 2001
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
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 53
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K012419.
NEOSPORIN SCAR SOLUTION
K024160 · Warner-Lambert Co. · Mar 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
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
K003979 · Medtrade Products , Ltd. · Mar 2001
SPECTRUM DESIGNS SPECTRAGEL
K992522 · Spectrum Designs, Inc. · Oct 1999
SCAREASE SHEETS & SCAREASE GEL
K991970 · Pillar Surgical · Oct 1999