# K132343: Marigen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Kerecis Limited
- Decided: Oct 23, 2013 after 85 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: 7 generations back to K921895 (1992). 63 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092096: Endoform Dermal Template, Mesynthes, Ltd. (2010) Summary page 1.
- K092926: Acell Matristem Wound Sheet, Acell, Inc. (2009) Summary page 1.
- K021792: Bilayer Matrix Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 1.
- K082103: LTM Wound Dressing, Lifecell Corp. (2008) Summary page 1.
- K083440: Primatrix Dermal Repair Scaffold, Tei Biosciences, Inc. (2008) Summary page 1.
- K071519: Hemcon Chitoflex-Surgical Dressing, Hemcon, Inc. (2007) Summary page 1.
- K061711: Oasis Wound Matrix, Cook Biotech, Inc. (2006) Summary page 1.

## Most influential descendants
- K190528: MariGen Wound Extra (2019), 3 descendants of its own
- K241080: Kerecis Parvus (50207) (2024), 1 descendant of its own
- K213231: Kerecis Silicone (2022), 1 descendant of its own
- K251845: Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (2025), 0 descendants of its own
- K153364: Kerecis SecureMesh (2016), 0 descendants of its own

## Indications for use
MauiGen Wound Dressing is indicated for the management of wounds including: - Partial- and MIl-thickness wounds - Pressure ulcers - venous ulcers - Chronic vascular ulcers - Diabetic ulcers - Trauma wounds (abrasions, lacerations, second-degree bums, skin tears) - Surgical wounds (donor sites/grafts, post-Mobs surgery, post-laser surgery, podiatric, wound dehiscence), and - Draining wounds.

Source page: https://510kreport.com/device/K132343
Methodology: https://510kreport.com/methodology