# K171645: CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle

- Pathway: 510(k) (Traditional)
- Applicant: Strukmyer Medical
- Decided: Jul 25, 2017 after 50 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012990 (2001). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012990: Collatek Powder, Biocore Medical Technologies, Inc. (2001) Summary page 4.

## Most influential descendants
- K260596: Collagen Wound Powder (2026), 0 descendants of its own
- K254034: Roosin Collagen Powder (2026), 0 descendants of its own
- K232796: LUOFUCON® Collagen Particles (Collagen Wound Dressing) (2024), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class III · Z-1789-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Thi

## Indications for use
CoMatryx Collagen Wound Dressing may be used in the management of partial and full thickness wounds, pressure (stage 1-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, 1st and 2nd degree burns, cuts, abrasions, and surgical wounds.

Source page: https://510kreport.com/device/K171645
Methodology: https://510kreport.com/methodology