# K212766: Maxiocel Chitosan Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Advamedica, Inc.
- Decided: Aug 24, 2023 after 723 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: 7 generations back to K914575 (1991). 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)
- K143124: KA01 Chitosan Wound Dressing, Foshan United Medical Technologies, Ltd. (2015) Summary page 6.
- K070175: Aquanova Super-Absorbent Gelling Dressing, Otc, Medtrade Products, Ltd. (2007) Summary page 6.

## Indications for use
The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration. Under medical supervision, the Maxiocel Chitosan Wound Dressing may be used for the management of the following wounds: • Pressure sores • Diabetic ulcers • Leg ulcers • Donor sites and graft sites • Surgical wounds • Skin abrasions and lacerations • 1st and 2nd degree bums • Trauma wounds

Source page: https://510kreport.com/device/K212766
Methodology: https://510kreport.com/methodology