Cleared Traditional

K880329 - FACTOR II PROSTHETIC SILICONE ELASTOMER

K880329 is the FDA 510(k) clearance for FACTOR II PROSTHETIC SILICONE ELASTOMER by Factor, Ii, Inc.. It is a Class 1 General & Plastic Surgery device (product code GBI) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K880329 · Factor, Ii, Inc. · General & Plastic Surgery device
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Jun 1988
Decision
127d
Days
Class 1
Risk

K880329 is an FDA 510(k) clearance for the FACTOR II PROSTHETIC SILICONE ELASTOMER. Classified as Material, External Aesthetic Restoration, Used With Adhesive (product code GBI), Class I - General Controls.

Submitted by Factor, Ii, Inc. (Lakeside, US). The FDA issued a Cleared decision on June 1, 1988 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3800 - 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 Factor, Ii, Inc. devices

Submission Details

510(k) Number K880329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date June 01, 1988
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBI Material, External Aesthetic Restoration, Used With Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3800
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 - GBI Material, External Aesthetic Restoration, Used With Adhesive

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