# K190528: MariGen Wound Extra

- Pathway: 510(k) (Traditional)
- Applicant: Kerecis Limited
- Decided: Jul 10, 2019 after 128 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). 64 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132343: Marigen Wound Dressing, Kerecis Limited (2013) Summary page 4.

## Most influential descendants
- 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

## Indications for use
MariGen Wound Extra is indicated for the management of wounds, including: - Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - Chronic vascular ulcers - Diabetic ulcers - Trauma wounds (second degree burn, abrasions, lacerations, skin tears), - Surgical wounds (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence), - Draining wounds.

Source page: https://510kreport.com/device/K190528
Methodology: https://510kreport.com/methodology