# K233378: ABCcolla® Collagen ADM Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Acro Biomedical Co., Ltd.
- Decided: Oct 18, 2024 after 382 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: 9 generations back to K921895 (1992). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162348: ABCcolla Collagen Matrix, Acro Biomedical Co., Ltd. (2017) Summary page 5.

## Indications for use
ABCcolla® Collagen ADM Scaffold is intended to be used for management of wounds, including 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/K233378
Methodology: https://510kreport.com/methodology