# K963039: Sureskin Standard, Border, and Thin

- Pathway: 510(k) (Traditional)
- Applicant: Euromed A/S
- Decided: Sep 23, 1996 after 49 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The SureSkin™ Hydrocolloid Wound Dressings manufactured by Euromed A/S are indicated for the management of dry and exudating pressure sores and leg ulcers.

Source page: https://510kreport.com/device/K963039
Methodology: https://510kreport.com/methodology