# K260669: Endoform Dermal Template

- Pathway: 510(k) (Traditional)
- Applicant: Aroa Biosurgery, Ltd.
- Decided: Jun 24, 2026 after 114 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: 7 generations back to K921895 (1992). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092096: Endoform Dermal Template, Mesynthes, Ltd. (2010) Summary page 5.

## Indications for use
Endoform Dermal Template is supplied sterile and is intended for single use in the management of the following wounds: * Partial and full thickness wounds * Pressure ulcers * Venous ulcers * Diabetic ulcers * Chronic vascular ulcers * Tunneled/undermined wounds * Surgical wounds (donor sites, grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence) * Traumatic wounds (abrasions, lacerations, partial-thickness burns, and skin tears) * Draining wounds

Source page: https://510kreport.com/device/K260669
Methodology: https://510kreport.com/methodology