# K172593: XCelliStem Wound Powder

- Pathway: 510(k) (Traditional)
- Applicant: Stemsys
- Decided: Mar 16, 2018 after 199 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). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152033: Cook ECM Powder, Cook Biotech Incorporated (2015) Summary page 4.
- K060888: Acell Powder Wound Dressing, Acell, Inc. (2006) Summary page 4.

## Most influential descendants
- K232204: ReyaGel (RG03 - MTP gel 3mL) (2024), 0 descendants of its own

## Indications for use
The XCelliStem Wound Powder is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, chronic vascular ulcers, tunneled/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), and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K172593
Methodology: https://510kreport.com/methodology