# K162759: KeraStat (R) Gel

- Pathway: 510(k) (Traditional)
- Applicant: Keranetics, LLC
- Decided: Jun 2, 2017 after 245 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). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080949: Keratec Wound Dressings, Keratec Limited (2009) Summary page 4.

## Most influential descendants
- K192386: KeraStat Cream (2020), 0 descendants of its own

## Indications for use
KeraStat® Gel is intended to provide a moist environment and absorb excess wound exudate. KeraStat® Gel is indicated for management of a number of partial thickness skin wounds such as: partial thickness (first and second degree) burns, severe sunburns, superficial injuries, cuts, abrasions, and incisions/surgical wounds. Under the direction of a healthcare practitioner, KeraStat® Gel also may be used in the management of dry, light, and moderately exuding partial thickness wounds including: pressure (stage I-II) ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites, and grafts. KeraStat® Gel is not indicated for full thickness (third degree) burns. This device will be available by prescription.

Source page: https://510kreport.com/device/K162759
Methodology: https://510kreport.com/methodology