# K213498: PELNAC Meshed Bilayer Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Gunze Limited
- Decided: Jul 14, 2022 after 255 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: 5 generations back to K881854 (1988). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081635: Integra Meshed Bilayer Wound Matrix, Integra Lifesciences Corp. (2008) Summary page 4.

## Indications for use
PELNAC® Meshed Bilayer Wound Matrix is indicated for the management of wounds including: * partial and full-thickness wounds, * pressure ulcers, * venous ulcers, * diabetic ulcers, * chronic vascular ulcers, * surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), * trauma wounds (abrasions, lacerations, partial thickness bums, and skin tears), and * draining wounds. The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.

Source page: https://510kreport.com/device/K213498
Methodology: https://510kreport.com/methodology