# K960254: Silgel Topical Gel Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Rofil Medical USA, Inc.
- Decided: Apr 2, 1996 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
Longest line of descent: 1 generation back to K894226 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894226: Silastic Soft Sheeting, Dow Corning Wright (1990) Summary page 1.
- (no number) Spenco Silicone Gelsheet: named in the summary without a submission number
- (no number) Epi-Derm Silicone Gel Sheeting: named in the summary without a submission number
- (no number) New Beginnings Topical Gel Sheeting: named in the summary without a submission number
- (no number) DermaSof, Gel Sheeting: named in the summary without a submission number
- (no number) Cica-Care Adhesive Gel Sheet: named in the summary without a submission number

## Most influential descendants
- K991968: Cicacare Roll-on Gel-Scar Management Liquid Gel. (1999), 0 descendants of its own

## Indications for use
Silgel is intended for use in the management of hypertrophic and keloid scars, prophylactic management of healed incisions and as a splint lining insert to relieve friction on newly healed scars.

Source page: https://510kreport.com/device/K960254
Methodology: https://510kreport.com/methodology