Cleared Traditional

K963128 - NOVAGEL SILICONE GEL SHEETING

K963128 is an FDA 510(k) clearance for NOVAGEL SILICONE GEL SHEETING, manufactured by Brennen 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 115-day FDA review.

K963128 · Brennen Medical, Inc. · General & Plastic Surgery device
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Dec 1996
Decision
115d
Days
Class 1
Risk

K963128 is an FDA 510(k) clearance for the NOVAGEL SILICONE GEL SHEETING. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Brennen Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 5, 1996 after a review of 115 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 Brennen Medical, Inc. devices

FDA 510(k) Submission Details - K963128

510(k) Number K963128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date December 05, 1996
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
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 9
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K963128.
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · Smith & Nephew, Inc. · Jul 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · Smith & Nephew, Inc. · Jul 1999
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
K964846 · Implantech Associates, Inc. · Feb 1997
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · Mentor Corp. · Aug 1996
CICA-CARE SILICONE GEL SHEET
K935803 · Smith & Nephew United, Inc. · Feb 1994