Cleared Traditional

K010675 - ENSIL FABRIC

K010675 is an FDA 510(k) clearance for ENSIL FABRIC, manufactured by Gottfried Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K010675 · Gottfried Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
85d
Days
Class 1
Risk

K010675 is an FDA 510(k) clearance for the ENSIL FABRIC. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Gottfried Medical, Inc. (Toledo, US). The FDA issued a Cleared decision on May 30, 2001 after a review of 85 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 Gottfried Medical, Inc. devices

FDA 510(k) Submission Details - K010675

510(k) Number K010675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2001
Decision Date May 30, 2001
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 57
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K010675.
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.
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GELZONE
K013732 · Implantech Associates, Inc. · Feb 2002
CONFORM SHEETING, MODEL IGEL
K012419 · Implantech Associates, Inc. · Oct 2001
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