# K061232: Acryderm Silver Antimicrobial Thin Film, Model 2006

- Pathway: 510(k) (Traditional)
- Applicant: Acrymed, Inc.
- Decided: Oct 6, 2006 after 157 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- 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) SilvaSorb Silver Antimicrobial Wound Dressing: named in the summary without a submission number
- (no number) Opsite Dressing: named in the summary without a submission number
- (no number) Arglaes Antimicrobial Wound Dressing: named in the summary without a submission number

## Recalls of this device
- Jun 30, 2008 · Not classified · Z-0306-2012: The Silver Dressing, lot H0705J and H0706J may contain dressings that are not properly sealed in the foil pouch, which could affect sterility of the dressing.

## Indications for use
To secure devices such as indwelling catheters, drains, monitoring leads and airway management apparatus to patients skin. For use as a cover dressing or in direct contact of wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, first and second degree burns, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

Source page: https://510kreport.com/device/K061232
Methodology: https://510kreport.com/methodology