# K941149: Dermaassist Hydrocolloid Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Wilshire Medical Products
- Decided: May 20, 1994 after 71 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 DermAssist™ Hydrocolloid Dressings are intended to provide optimal environments ideally suited for chronic wound management. The dressings are soft, conformable hydrocolloid dressings for moderate to light exuding wounds. The dressings react with wound moisture to form a gelatinous mass providing a moist healing environment. The hydrocolloid gel also helps to reduce the potential for tissue damage during dressing changes. Due to their highly conformable nature, the DermAssist™ Hydrocolloid Dressings may be used in areas difficult to dress such as the coccyx area, around joints, heels, elbows and other body contours difficult to cover with conventional dressings.

Source page: https://510kreport.com/device/K941149
Methodology: https://510kreport.com/methodology