# K060804: Collagran-Collagen Wound Dressing, Collagranag-Collagen W/Silver Antimicrobial Wound Dressing

- Pathway: 510(k) (Special)
- Applicant: Covalon Technologies, Ltd.
- Decided: Apr 18, 2006 after 25 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- May 25, 2022 · Class III · Z-1796-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Thi

## Indications for use
The Collagran wound dressing and Collagran Ag wound dressing are intended to be used for the following conditions: the management of full and partial thickness wounds including: * pressure ulcers, * diabetic ulcers, * ulcers caused by mixed vascular etiologies, * venous ulcers, - first and second degree bums, - donor and graft sites, * abrasions and lacerations, * dehisced surgical wounds, * traumatic wounds healing by secondary intention

Source page: https://510kreport.com/device/K060804
Methodology: https://510kreport.com/methodology