# K012116: Acryderm Silver Antimicrobial Perforated Wound Dressing

- Pathway: 510(k) (Special)
- Applicant: Acrymed, Inc.
- Decided: Sep 12, 2001 after 68 days
- Product code: FRO (Dressing, Wound, Drug)
- 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) AcryDerm Silver Antimicrobial Strands: named in the summary without a submission number

## Indications for use
AcryDerm Silver Antimicrobial Perforated Dressing is an effective barrier to bacterial penetration. The antimicrobial barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds.

Source page: https://510kreport.com/device/K012116
Methodology: https://510kreport.com/methodology