# K970693: Acryderm Gel Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Acrymed, Inc.
- Decided: Mar 21, 1997 after 24 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) AcryDerm Advanced Wound Dressing: named in the summary without a submission number
- (no number) IntraSite Gel: named in the summary without a submission number
- (no number) Carrasyn Hydrogel Wound Dressing: named in the summary without a submission number

## Most influential descendants
- K080471: Radio Bioaquacare (2008), 0 descendants of its own

## Indications for use
AcryDerm Gel is an external wound dressing that is designed as a moisture donating substrate for use in promoting natural autolytic debridement by rehydrating necrotic tissues. AcryDerm Gel is indicated for use as an external wound dressing in the management of chronic wounds such as pressure sores, diabetic ulcers, radiation dermatitis, peristomal skin irritations, and stasis ulcers, and acute wounds such as surgical wounds, lacerations, donor site, first and second degree burns, and abrasions. AcryDerm Gel may be used on infected wounds under medical supervision. AcryDerm Gel is not intended as a long duration dressing for the treatment of third degree burns.

Source page: https://510kreport.com/device/K970693
Methodology: https://510kreport.com/methodology