# K984593: Modification of Cutinova Thin 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 K944581 (1994). 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)
- K944581: Cutinova Thin Wound Dressing, Beiersdorf, Inc. (1994) Summary page 1.

## Indications for use
Cutinova thin is a dressing indicated for the management of surface wounds with low to moderate exudate, such as: Minor burns Abrasions Cutinova thin may also be used under the direction of 8 health care professional for partial thickness wounds such as: Second degree burns Leg ulcers Pressure ulcers Post-op wounds Donor sites Cutinova thin is indicated for the management of surface wounds with low to moderate exudate, such as: First and second degree burns Follow-up management of abrasions and donor sites Partial thickness wounds Leg ulcers Stage I & II pressure ulcers Post-operative wounds

Source page: https://510kreport.com/device/K984593
Methodology: https://510kreport.com/methodology