# K040019: Silverseal

- Pathway: 510(k) (Traditional)
- Applicant: Noble Fiber Technologies
- Decided: Jul 23, 2004 after 199 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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 K973688 (1997). 11 ancestors in all.
97 later devices descend from it; 3 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980132: Phytacare Alginate Hydrogel Wound Dressing, Phytatek Laboratories, Inc. (1998) Summary page 1.
- K010583: Ambu Gel, Hydrogel Burn Dressing, Ambu, Inc. (2001) Summary page 1.
- K022995: Collatek Hydrogel, Biocore Medical Technologies, Inc. (2002) Summary page 1.
- K991202: Modification to Woun'dres, Coloplast Corp. (1999) Summary page 1.
- K983362: NU-Gel * Wound Dressing, Johnson & Johnson Medical, Inc. (1998) Summary page 1.
- K990368: Duoderm Hydroactive Gel Wound Dressing, Convatec, A Bristol-Myers Squibb Co. (1999) Summary page 1.
- K011994: Acryderm Silver Anttimicrobial Wound Gel Model# a-002101, Acrymed, Inc. (2001) Summary page 1.
- K002466: Acticoat Composite Dressing, Westaim Biomedical, Inc. (2001) Summary page 1.

## Most influential descendants
- K063069: Silvaklenz Skin and Wound Clenser Solution (2007), 73 descendants of its own
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser (2009), 37 descendants of its own
- K100918: Vashe Wound Therapy System Model: 9000-0014 (2010), 31 descendants of its own
- K123072: Vashe Wound Therapy Solution (2013), 25 descendants of its own

## Indications for use
The X-Static® SilversealTM Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.

Source page: https://510kreport.com/device/K040019
Methodology: https://510kreport.com/methodology