# K973806: Duoderm Hydroactive Gel

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Bristol-Myers Squibb Co.
- Decided: Dec 29, 1997 after 84 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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

## Most influential descendants
- K143058: PuraDerm Gel (2015), 3 descendants of its own
- K182681: AC5 Topical Gel (2018), 1 descendant of its own
- K193085: PuraDERM Gel (2020), 0 descendants of its own
- K190129: AC5 Topical Gel (2020), 0 descendants of its own

## Indications for use
DuoDERM Hydroactive Gel is designed for the hydration and management of partial and full thickness wounds such as pressure sores, leg ulcers, and diabetic ulcers. DuoDERM Hydroactive Gel provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing without damaging newly formed tissue,

Source page: https://510kreport.com/device/K973806
Methodology: https://510kreport.com/methodology