Cleared Traditional

K991968 - CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.

K991968 is an FDA 510(k) clearance for CICACARE ROLL-ON GEL-SCAR MANAGEMENT LI..., manufactured by Smith & Nephew, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K991968 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
49d
Days
Class 1
Risk

K991968 is an FDA 510(k) clearance for the CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Largo, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 49 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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K991968

510(k) Number K991968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1999
Decision Date July 30, 1999
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
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 55
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K991968.
SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
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CICACARE MANAGEMENT FOR SCARS
K991957 · Smith & Nephew, Inc. · Jul 1999
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K991478 · Capital Marketing Technologies, Inc. · Jun 1999