# K152033: Cook ECM Powder

- Pathway: 510(k) (Special)
- Applicant: Cook Biotech Incorporated
- Decided: Aug 19, 2015 after 28 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: 1 generation back to K061711 (2006). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061711: Oasis Wound Matrix, Cook Biotech, Inc. (2006) Summary page 4.

## Most influential descendants
- K172399: MicroMatrix (2017), 3 descendants of its own
- K230980: MicroMatrix® Flex (2023), 1 descendant of its own
- K172593: XCelliStem Wound Powder (2018), 1 descendant of its own
- K253521: Ecmt-100 WMD (2026), 0 descendants of its own
- K241706: MicroMatrix® UBM Particulate (2024), 0 descendants of its own

## Indications for use
Indications For Use: Cook® ECM Powder is intended for the management of wounds including: • 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) • trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) • draining wounds The device is provided sterile and intended for one-time use.

Source page: https://510kreport.com/device/K152033
Methodology: https://510kreport.com/methodology