# K974890: Acutek's Hydrocolloid Wound Dressing, Tib 997002

- Pathway: 510(k) (Traditional)
- Applicant: Acutek Adhesive Specialties, Inc.
- Decided: Oct 13, 1998 after 287 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Hydrocolloid Dressing is intended for the management of lightly to moderately exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: venous stasis ulcers, pressure ulcers, surgical incision sites, and minor bums.

Source page: https://510kreport.com/device/K974890
Methodology: https://510kreport.com/methodology