# K983249: Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin

- Pathway: 510(k) (Traditional)
- Applicant: Euromed, Inc.
- Decided: Nov 25, 1998 after 70 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
Longest line of descent: 1 generation back to K853844 (1985). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960393: Sureskin Border, Euromed A/S (1996) Summary page 1.
- K960394: Sureskin Standard, Euromed A/S (1996) Summary page 1.
- K960404: Sureskin Thin, Euromed A/S (1996) Summary page 1.
- K863390: Hydrocolloid Dressings - Sterile, Convatec, A Division of E.R. Squibb & Sons (1986) Summary page 1.
- K853844: Duoderm Hydroactive Dressing W/Border Sterile, Convatec, A Division of E.R. Squibb & Sons (1985) Summary page 1.

## Most influential descendants
- K992363: Sureskin II Standard, Sureskin II Border, Sureskin II Thin (1999), 3 descendants of its own
- K050032: Euromed Sureskin Iii with Silver Wound Dressings (2006), 2 descendants of its own
- K081274: Sureskin Silver Bandages (2008), 1 descendant of its own
- K151186: Stay Fresh Hydrocolloid dressing (2015), 0 descendants of its own

## Indications for use
The SureSkin™ Plus STANDARD and SureSkin™ Plus BORDER hyclrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers. The SureSkin™ Plus THIN hydrocolloid wound dressing is indicated for the management of clry to lightly exudating wounds, such as pressure sores and leg ulcers. The SureSkin™ Plus dressings are also indicated for use on su erficial wounds and alarasions. second degree burns, and donor sites.

Source page: https://510kreport.com/device/K983249
Methodology: https://510kreport.com/methodology