# K123756: Covagen

- Pathway: 510(k) (Traditional)
- Applicant: Covalon Technologies, Ltd.
- Decided: Aug 16, 2013 after 252 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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 K061554 (2007). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050177: Colactive Collagen Wound Dressing, Covalontechnologies, Inc. (2005) Summary page 1.
- K123892: Mepilex Transfer AG, Molnlycke Health Care (2013). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K192346: scaffolene CL100 Bioresorbable Collagen Matrix (2020), 0 descendants of its own

## Indications for use
CalActive® Transfer, is indicated for management of full and partial thickness wounds including pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention.

Source page: https://510kreport.com/device/K123756
Methodology: https://510kreport.com/methodology