# K022127: Avagen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Sep 10, 2002 after 71 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: 3 generations back to K881854 (1988). 9 ancestors in all.
28 later devices descend from it; 10 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993948: Sis Wound Dressing II, Cook Biotech, Inc. (2000) Summary page 1.
- K014129: Promogran Matrix Wound Dressing, Johnson & Johnson Medical, Ltd. (2002)

## Most influential descendants
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- K072113: Integra Flowable Wound Matrix, Model FWD301 (2007), 5 descendants of its own
- K170300: Restrata Wound Matrix (2017), 4 descendants of its own
- K161067: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” (2016), 3 descendants of its own
- K222189: SiOxD Wound Matrix (2022), 2 descendants of its own

## Indications for use
AVAGEN Wound Dressing is indicated for the management of wollnds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneledundermined wounds, surgical wounds (donor sitedgrafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree bums, skin tears) and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K022127
Methodology: https://510kreport.com/methodology