# K012419: Conform Sheeting, Model Igel

- Pathway: 510(k) (Traditional)
- Applicant: Implantech Associates, Inc.
- Decided: Oct 24, 2001 after 86 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013732: Gelzone (2002), 0 descendants of its own

## Indications for use
Conform Sheeting is indicated for use in the management of keloid and hypertrophic scars. Conform Sheeting may also be used prophylactically to help retard the formation of such scars.

Source page: https://510kreport.com/device/K012419
Methodology: https://510kreport.com/methodology