# K984029: Silgel STC-S

- Pathway: 510(k) (Traditional)
- Applicant: Nagor, Ltd.
- Decided: Aug 5, 1999 after 266 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 K954413 (1995). 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)
- K954413: Kelocote, Allied Biomedical Corp. (1995) Summary page 1.
- (no number) Xeragel: named in the summary without a submission number
- (no number) Zeraderm: named in the summary without a submission number
- (no number) Scar Fade: named in the summary without a submission number
- (no number) Spectragel: named in the summary without a submission number

## Indications for use
Silgel™ STC-S is intended for use in the management of keloid and hypertrophic scars and associated erythema.

Source page: https://510kreport.com/device/K984029
Methodology: https://510kreport.com/methodology