# K974172: Silgel Topical Gel Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Nagor, Ltd.
- Decided: Mar 30, 1998 after 145 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.
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)
- 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

## Indications for use
Silgel™ device is intended for use in the management of hypertrophic and keloid scars. It can also be used for the prophylactic management of healed incisions for the prevention of hypertrophic or keloid scars. Silgel helps relieve friction on newly healed scars when used as a splint lining insert.

Source page: https://510kreport.com/device/K974172
Methodology: https://510kreport.com/methodology