# K260532: Derma-Gide

- Pathway: 510(k) (Special)
- Applicant: Geistlich Pharma AG
- Decided: Mar 19, 2026 after 30 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 K061711 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182838: Geistlich Derma-Gide, Geistlich Pharma AG (2018) Summary page 5.
- K171842: Geistlich Wound Matrix, Geistlich Pharma AG (2017) Summary page 5.

## Indications for use
Derma-Gide is intended for the management of wounds including: • partial and full thickness wounds • pressure ulcers • venous ulcers • diabetic ulcers • chronic vascular ulcers • surgical wounds (donor sites/grafts, post Moh’s surgery, post laser surgery, podiatric, wound dehiscence) • trauma skin wounds (abrasions, laceration, partial thickness second degree burns, skin tears)

Source page: https://510kreport.com/device/K260532
Methodology: https://510kreport.com/methodology