# K973689: Duoderm Hydroactive Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, Ltd.
- Decided: Dec 23, 1997 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SignaDRESS Hydrocolloid Dressing: named in the summary without a submission number

## Indications for use
DuoDERM Hydroactive Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM Hydroactive Dressing provides a moist wound environment that is suppartive of the healing process by siding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue.

Source page: https://510kreport.com/device/K973689
Methodology: https://510kreport.com/methodology