# K973632: Duoderm CGF Control Gel Formula Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: Dec 22, 1997 after 89 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 CGF Control Gel Formula Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and on acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM CGF Control Gel Formula Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue.

Source page: https://510kreport.com/device/K973632
Methodology: https://510kreport.com/methodology