# K014036: Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar Therapy Gel, Model 09916030.

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Feb 14, 2002 after 69 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002488 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002488: Kelo-Cote Topical Gel, Advanced Bio-Technologies, Inc. (2001) Summary page 1.

## Most influential descendants
- K083718: Beau RX Scar Care Gel (2009), 1 descendant of its own
- K131672: Microcyn Scar Management Hydrogel (2013), 0 descendants of its own

## Indications for use
MedTrade Product's Silicone Scar Gel is intended for the management of: Old and new hypertropic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds Help Soften, Smooth and Flatten Scars It is not indicated for use on: Open or infected wounds, scabs or stitches New wounds which have breached the dermis Materials present in the product do not contra-indicate topical (skin/scar) applications. The components do not contain animal ingredients.

Source page: https://510kreport.com/device/K014036
Methodology: https://510kreport.com/methodology