# K962917: Multidex Hydrophilic Wound Dressing Gel

- Pathway: 510(k) (Traditional)
- Applicant: Lange Medical Products, Inc.
- Decided: Dec 16, 1996 after 143 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 no predicate by number.

## Indications for use
MULTIDEX*® Gel in a multi-use container is indicated for the management of stage I, III, IV pressure sores/ulcers, venous stasis ulcers, varicose ulcers, ischemic arterial ulcers, diabetic ulcers, neuropathic ulcers, poorly healing non-neoplastic wounds/ulcers and wounds/ulcers due to trauma.

Source page: https://510kreport.com/device/K962917
Methodology: https://510kreport.com/methodology