# K172318: Endoform Silver Dermal Template

- Pathway: 510(k) (Traditional)
- Applicant: Aroa Biosurgery
- Decided: Nov 17, 2017 after 108 days
- Product code: FRO (Dressing, Wound, Drug)
- 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 K881854 (1988). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100261: Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold, Tei Biosciences, Inc. (2010) Summary page 4.

## Indications for use
Endoform Silver 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 * tunnelled / undermined wounds * surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) * trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) * draining wounds

Source page: https://510kreport.com/device/K172318
Methodology: https://510kreport.com/methodology