# K192346: scaffolene CL100 Bioresorbable Collagen Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Freudenberg Technology Innovation SE & Co. KG
- Decided: Feb 28, 2020 after 183 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: 4 generations back to K061554 (2007). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123756: Covagen, Covalon Technologies, Ltd. (2013) Summary page 4.

## Indications for use
scaffolene® CL100 Bioresorbable Collagen Matrix is indicated for the management of full and partial thickness wounds in adult patients 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/K192346
Methodology: https://510kreport.com/methodology