# K981902: Spenco Silicone Gel Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Spenco Medical Corp.
- Decided: Jun 25, 1998 after 24 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K991630: Advanced Medical Solutions-Silicone Gel Scar Management Sheet (1999), 0 descendants of its own

## Indications for use
Spenco Silicone Gel Sheet is indicated for: 1. Use as a scar management dressing on old and new hyperthropic or keloid scars. Not to be used on infected wounds Is not indicated for use on 3rd degree burns The device can be used by layman, safely when following the instructions-for use included with the product.

Source page: https://510kreport.com/device/K981902
Methodology: https://510kreport.com/methodology