# K984204: Silverlon Direct Pressure Wound Closure Strip

- Pathway: 510(k) (Traditional)
- Applicant: Argentum International, LLC
- Decided: Mar 19, 2007 after 3,037 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
Longest line of descent: 3 generations back to K914579 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813265: 3M Steri-Strip Antimicrobial Skin Clos, 3M Company (1983) Summary page 2.
- K842621: Suture Strip, Genetic Laboratories, Inc. (1984) Summary page 2.
- K981299: Silverlon Contact Wound Dressing, Argentum International, LLC (1998) Summary page 2.

## Indications for use
Silverlon™ Direct Pressure (DP) Wound Closure Strips are absorbent antimicrobial barrier dressings. Local management of superficial wounds and skin tears and minor lacerations. Primary or secondary closure following surgery, supplementary-support to sutures, staples or sealants, wound support following suture removal, and wound sites where suturing would aggravate bleeding.

Source page: https://510kreport.com/device/K984204
Methodology: https://510kreport.com/methodology