# K973716: Duoderm Extra Thin CGF Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Bristol-Myers Squibb Co.
- Decided: Dec 17, 1997 after 79 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K082208: Doctors Choice Slow Healing Bandage with Spray on Remover (2008), 0 descendants of its own

## Indications for use
DuoDERM Extra Thin CGF Dressings is indicated for use on chronic wounds-dry to lightly exuding dermal ulcers, including diabetic ulcers; acute wounds-surgical wounds (e.g., post operative wounds); and as a protective dressing for areas at risk for skin breakdown. DuoDERM Extra Thin CGF Dressing provides a moist wound environment that is necessary for the healing process.

Source page: https://510kreport.com/device/K973716
Methodology: https://510kreport.com/methodology