# K973688: Duoderm Control Gel Formula Border 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.
110 later devices descend from it; 3 cite it directly.
0 of 111 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
- K983362: NU-Gel * Wound Dressing (1998), 107 descendants of its own
- K022995: Collatek Hydrogel (2002), 106 descendants of its own
- K040019: Silverseal (2004), 97 descendants of its own
- K063069: Silvaklenz Skin and Wound Clenser Solution (2007), 73 descendants of its own
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own

## Indications for use
DuoDERM CGF Control Gel Formula Border Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and acute wounds such as superficial wounds (e.g. minor abrasions), second degree burns and donor sites. DuoDERM CGF Control Gel Formula Border Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement

Source page: https://510kreport.com/device/K973688
Methodology: https://510kreport.com/methodology