# K191992: PELNAC Bilayer Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Gunze Limited
- Decided: Apr 29, 2020 after 279 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: 4 generations back to K881854 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022127: Avagen Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 4.

## Indications for use
PELNAC™ 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, second-degree burns, and skin tears), and • draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K191992
Methodology: https://510kreport.com/methodology