# K251845: Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus

- Pathway: 510(k) (Special)
- Applicant: Kerecis Limited
- Decided: Jul 16, 2025 after 30 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: 10 generations back to K921895 (1992). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190528: MariGen Wound Extra, Kerecis Limited (2019) Summary page 5.
- K213231: Kerecis Silicone, Kerecis Limited (2022) Summary page 5.
- K241080: Kerecis Parvus (50207), Kerecis Limited (2024) Summary page 6.

## Indications for use
Kerecis® Marigen Wound Extra Autologous Hydration, Kerecis Silicone Autologous Hydration and Kerecis Parvus Autologous Hydration Management of wounds including: • Partial thickness wounds • Full thickness wounds • Pressure ulcers • Venous ulcers • Chronic vascular ulcers • Diabetic ulcers • Trauma wounds (abrasions, lacerations, partial thickness bums, skin tears) • Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) • Draining wounds

Source page: https://510kreport.com/device/K251845
Methodology: https://510kreport.com/methodology