Cleared Traditional

DURASIL (MODIFICATION) (K961410) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K961410 · The S. F. Group, Inc. · General & Plastic Surgery device
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Sep 1996
Decision
175d
Days
Class 1
Risk

K961410 is an FDA 510(k) clearance for the DURASIL (MODIFICATION). Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by The S. F. Group, Inc. (Grand Junction, US). The FDA issued a Cleared decision on September 3, 1996 after a review of 175 days - an extended review 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: 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 The S. F. Group, Inc. devices

Submission Details

510(k) Number K961410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1996
Decision Date September 03, 1996
Days to Decision 175 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 115d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.