# K081724: Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan) Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Applied Nutritionals
- Decided: Oct 30, 2008 after 134 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). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955506: Hycure, The Hymed Group Corp. (1996) Summary page 1.
- K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram, Integra Lifesciences Corp. (1999) Summary page 1.
- K021792: Bilayer Matrix Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 1.
- K961930: Chondroprotec, The Hymed Group Corp. (1996) Summary page 1.
- K072113: Integra Flowable Wound Matrix, Model FWD301, Integra Lifesciences Corp. (2007) Summary page 1.

## Indications for use
Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound gel is indicated for topical use in the management of chronic and acute wounds and dermal ulcers including the local management of: * Pressure Ulcers (Stage I-IV) * Venous Stasis Ulcers * Diabetic Ulcers * First and Second Degree Burns * Surgical wounds * Traumatic wounds * Superficial wounds * Ulcers resulting from arterial insufficiency * Grafted wounds and donor sites For over the counter use, Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel may be used for: - minor abrasions - lacerations - minor cuts - minor scalds and burns

Source page: https://510kreport.com/device/K081724
Methodology: https://510kreport.com/methodology