# K961085: Deroyal Wound Care Multidex Plus Gel Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Debusk Knitting Mills, Div. Deroyal Industries
- Decided: May 21, 1996 after 63 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
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 its predicate without a number.
- (no number) DeRoyal Industries, Inc., Multidex® Gel: named in the summary without a submission number
- (no number) Lange, Multidex® Plus Powder: named in the summary without a submission number

## Indications for use
The DeRoyal Industries, Inc. Multidex® Plus Gel is indicated for use for chronic, non-healing wounds, ulcers, and over burns to provide a protective film and a moist wound environment conducive to healing.

Source page: https://510kreport.com/device/K961085
Methodology: https://510kreport.com/methodology