# K050649: Silverseal Contacting Wound Dressing with X-Static

- Pathway: 510(k) (Traditional)
- Applicant: Noble Fiber Technologies, Inc.
- Decided: Jun 13, 2005 after 91 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: 5 generations back to K914579 (1992). 10 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033587: Silverseal, Noble Fiber Technologies (2004) Summary page 1.
- K023612: Silverlon Contact Wound Dressing, Argentum International, LLC (2003) Summary page 1.

## Most influential descendants
- K083133: Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam Dressings (2009), 3 descendants of its own
- K223360: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (2024), 1 descendant of its own
- K242856: LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) (2024), 0 descendants of its own
- K223359: LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing (2023), 0 descendants of its own
- K063190: Silverseal Wound Packing Strips with X-Static (2007), 0 descendants of its own

## Indications for use
For over-the-counter use, Silverseal® Wound Contact Dressing with X-Static® may be used for first aid management of minor abrasions, cuts, scrapes, scalds and burns. Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

Source page: https://510kreport.com/device/K050649
Methodology: https://510kreport.com/methodology