# K971916: Medical Z, S.a. Medigel Z Scar Management Gel

- Pathway: 510(k) (Traditional)
- Applicant: Medical Z, S.A.
- Decided: Jul 29, 1997 after 67 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 K942695 (1994). 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)
- K942695: Tri Block Polumer Gel Sheeting, Silipos, Inc. (1994) Summary page 3.
- (no number) Smith & Nephew Rolyan Cica-Care™ Silicone Gel Sheet: named in the summary without a submission number

## Indications for use
The Medigel Z products are indicated for temporary use in the management of hypertrophic scars and Keloids resulting from wounds, trauma, or burns. The Medigel Z products are not wound dressings and are not intended to be used on open wounds. It is recommended that the products be used after the closing of a wound (8th to 10th day), or just after the first sign of hypertrophic scars.

Source page: https://510kreport.com/device/K971916
Methodology: https://510kreport.com/methodology