# K974891: Acutek's Hydrocolloid Wound Dressing, Tib 197013

- Pathway: 510(k) (Traditional)
- Applicant: Acutek Adhesive Specialties, Inc.
- Decided: Oct 21, 1998 after 295 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 applications where gentle adhesion to the skin is desirable. Also, the dressing is intended for the management of lightly to heavily 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 burns.

Source page: https://510kreport.com/device/K974891
Methodology: https://510kreport.com/methodology