# K913140: Silicone Gel Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: Cui Corp.
- Decided: Sep 30, 1991 after 76 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971009: Scar Care (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K913140
Methodology: https://510kreport.com/methodology