Cleared Traditional

K991630 - ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET

K991630 is an FDA 510(k) clearance for ADVANCED MEDICAL SOLUTIONS-SILICONE GEL..., manufactured by Advanced Medical Solutions Group Plc. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K991630 · Advanced Medical Solutions Group Plc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
31d
Days
Class 1
Risk

K991630 is an FDA 510(k) clearance for the ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Advanced Medical Solutions Group Plc (Winsford, Cheshire, GB). The FDA issued a Cleared decision on June 11, 1999 after a review of 31 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 Advanced Medical Solutions Group Plc devices

FDA 510(k) Submission Details - K991630

510(k) Number K991630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1999
Decision Date June 11, 1999
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
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 51
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K991630.
SCARAID SILICONE GEL SHEETING
K992146 · Biodermis Corp. · Jul 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · Smith & Nephew, Inc. · Jul 1999
TENDER TOUCH SILICONE GEL PADS
K991478 · Capital Marketing Technologies, Inc. · Jun 1999
EPI-FOAM SILICONE SHEETING
K991604 · Biodermis Corp. · Jun 1999
AVOGEL
K981353 · Avocet Polymer Technologies, Inc. · Jun 1999
NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
K984213 · Capital Marketing Technologies, Inc. · Apr 1999