# K983042: Sween Woun'dres

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Nov 25, 1998 after 86 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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 K894541 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894541: Carrington Dermal Wound Gel, Carrington Laboratories, Inc. (1989) Summary page 1.
- K925993: Duoderm Hydroactive Dressing, Convatec, A Division of E.R. Squibb & Sons (1993) Summary page 1.

## Indications for use
May be used for superficial wounds and abrasions and minor burns. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, venous stasis, and diabetic ulcers; surgical wounds; first- and second-degree bums including management of abrasions and burns associated with dermmabrasion and laser resurfacing.

Source page: https://510kreport.com/device/K983042
Methodology: https://510kreport.com/methodology