# K162348: ABCcolla Collagen Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Acro Biomedical Co., Ltd.
- Decided: May 10, 2017 after 261 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: 8 generations back to K921895 (1992). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090894: Collawound Wound Dressing, Collamatrix Co., Inc. (2009) Summary page 4.

## Most influential descendants
- K233378: ABCcolla® Collagen ADM Scaffold (2024), 0 descendants of its own

## Indications for use
ABCcolla® Collagen Matrix is intended to be used for management of wounds, including partial and full thickness wounds, venous ulcers, pressure ulcers, chronic vascular ulcers, diabetic ulcers, tunneled/undermined wounds, surgical wounds (donor site/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, and skin tears), first and second-degree burns, draining wounds.

Source page: https://510kreport.com/device/K162348
Methodology: https://510kreport.com/methodology