# K052696: Covaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Covalon Technologies, Ltd.
- Decided: Feb 3, 2006 after 128 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: 1 generation back to K002599 (2000). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043296: Colactive AG Collagen with Silver Antimicrobial Dressing, Covalontechnologies, Inc. (2005) Summary page 1.
- K002599: Modification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041, 1042, 1043, 1044, 1045, Acrymed, Inc. (2000) Summary page 1.

## Most influential descendants
- K063059: Sorbact Wound Dressing (2007), 4 descendants of its own
- K143151: Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) (2015), 1 descendant of its own
- K171225: Sorbact Wound Dressing-Ribbon Gauze (2017), 0 descendants of its own
- K153674: Sorbact Foam Gentle Border, Sorbact Superabsorbent (2016), 0 descendants of its own
- K100591: Sorbact (2011), 0 descendants of its own

## Indications for use
CovaClearAg Collagen with Silver, Antimicrobial Gel Sheet Dressing is indicated for the management of full and partial thickness wounds including: pressure ulcers diabetic ulcers ulcers caused by mixed vascular etiologies venous ulcers donor and graft sites abrasions and lacerations traumatic wounds healing by secondary intention de hisced surgical wounds first and second degree burns

Source page: https://510kreport.com/device/K052696
Methodology: https://510kreport.com/methodology