# K984597: Modification of Cutinova Cavity Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Beiersdorf-Jobt, Inc.
- Decided: Mar 1, 1999 after 63 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 1 generation back to K952526 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952526: Cutinova Cavity, Beiersdorf, Inc. (1995) Summary page 1.

## Indications for use
Cutinova cavity is indicated for the management of deep secondary healing wounds such as: Cavity wounds Stage III and IV pressure ulcers Deep leg ulcers Excisions Post-op wound dehiscence Cutinova cavity may be used under the direction of 2 health care professional for the management of deep secondary healing wounds such as: Cavity wounds Stage III and IV pressure ulcers Deep leg ulcers Excisions Post-op wound dehiscence

Source page: https://510kreport.com/device/K984597
Methodology: https://510kreport.com/methodology