# K962513: Dermaplex Hydrogel Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Maxxim Medical
- Decided: Sep 12, 1996 after 77 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
Longest line of descent: 1 generation back to K950412 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950412: Curagel Hydrogel Wound Dressing, Kendall Healthcare Products Co. Div.Of Tyco Health (1995) Summary page 1.

## Indications for use
For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.

Source page: https://510kreport.com/device/K962513
Methodology: https://510kreport.com/methodology