Cleared Traditional

K981902 - SPENCO SILICONE GEL SHEET

K981902 is an FDA 510(k) clearance for SPENCO SILICONE GEL SHEET, manufactured by Spenco Medical Corp.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K981902 · Spenco Medical Corp. · General & Plastic Surgery device
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Jun 1998
Decision
24d
Days
Class 1
Risk

K981902 is an FDA 510(k) clearance for the SPENCO SILICONE GEL SHEET. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Spenco Medical Corp. (Waco, US). The FDA issued a Cleared decision on June 25, 1998 after a review of 24 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 Spenco Medical Corp. devices

FDA 510(k) Submission Details - K981902

510(k) Number K981902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1998
Decision Date June 25, 1998
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 56
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K981902.
SCAREASE & SCAREASE ADHESIVE GEL
K984115 · Scarease, Inc. · Feb 1999
SILON SCAR STRIPS
K982036 · Bio Med Sciences, Inc. · Aug 1998
KELOCATE SHEETING
K982051 · Allied Biomedical Corp. · Aug 1998
EVANESCE SCAR MANAGEMENT SYSTEM
K981387 · Medical Scientific, Inc. · Jun 1998
SKAR-KARE SHEET
K980563 · Life Medical Sciences, Inc. · May 1998
REJUVENESS
K974380 · Rejuveness Pharamceuticals, Inc. · Apr 1998