# K991630: Advanced Medical Solutions-Silicone Gel Scar Management Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions Group Plc
- Decided: Jun 11, 1999 after 31 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 K981902 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981902: Spenco Silicone Gel Sheet, Spenco Medical Corp. (1998) Summary page 2.

## Indications for use
Advanced Medical Solutions Silicone Gel Scar Management Sheet is intended for OTC use for the management of: Old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Source page: https://510kreport.com/device/K991630
Methodology: https://510kreport.com/methodology