# K033587: Silverseal

- Pathway: 510(k) (Traditional)
- Applicant: Noble Fiber Technologies
- Decided: Aug 5, 2004 after 266 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: 4 generations back to K914579 (1992). 9 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970566: Arglaes Film Dressing, Maersk Medical, Ltd. (1997) Summary page 1.
- K955453: Acticoat Silver Coated Dressing, Westaim Technologies, Inc. (1996) Summary page 1.
- K981299: Silverlon Contact Wound Dressing, Argentum International, LLC (1998) Summary page 1.
- K023612: Silverlon Contact Wound Dressing, Argentum International, LLC (2003) Summary page 1.
- K023609: Silverlon Adhesive Strip, Argentum International, LLC (2003) Summary page 1.
- K984210: Silverlon Wound Packing Strips, Argentum International, LLC (1999) Summary page 1.
- K890354: Tegapore Wound Contact Material, Product #563X, 3M Company (1989) Summary page 1.

## Most influential descendants
- K050649: Silverseal Contacting Wound Dressing with X-Static (2005), 5 descendants of its own
- K083133: Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam Dressings (2009), 3 descendants of its own
- K050726: Silverseal Silveraid with X-Static (2005), 2 descendants of its own
- K223360: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (2024), 1 descendant of its own
- K072378: Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625, AR-1626 (2007), 1 descendant of its own

## Indications for use
X-Static® SILVERSEAL" Contact Wound Dressings are sterile, non-adherent dressings intended for local 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/K033587
Methodology: https://510kreport.com/methodology