# K213231: Kerecis Silicone

- Pathway: 510(k) (Traditional)
- Applicant: Kerecis Limited
- Decided: Jun 29, 2022 after 272 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). 65 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 67 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 4.

## Most influential descendants
- K251845: Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (2025), 0 descendants of its own

## Indications for use
Kerecis Silicone is indicated for the management of wounds including: * Partial and 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/K213231
Methodology: https://510kreport.com/methodology