# K971482: Degania Silicone Sil-K

- Pathway: 510(k) (Traditional)
- Applicant: Degania Silicone, Ltd.
- Decided: Jun 24, 1997 after 64 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. The FDA summary names its predicate without a number.
- (no number) Degania Silicone Sil-K: named in the summary without a submission number

## Most influential descendants
- K974143: KMC Newskin (1998), 0 descendants of its own

## Indications for use
The Sil-K is designed and indicated for treating thick painful, itchy, red and raised hypertrophic or keloid scars.

Source page: https://510kreport.com/device/K971482
Methodology: https://510kreport.com/methodology