# K990964: Signadress Duoderm Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: May 18, 1999 after 56 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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) CombiDERM™ ACD™ Absorbent Cover Dressing: named in the summary without a submission number

## Indications for use
For Over-The-Counter use SignaDRESS™ DuoDERM® Dressing may be used on abrasions, lacerations, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a health care professional, SignaDRESS may be used for wounds such as leg ulcers ( venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology), pressure ulcers (Stage I-IV) and diabetic ulcers, surgical wounds (post-operative wounds, donor sites, dermatological excisions), and burns (first and second degree).

Source page: https://510kreport.com/device/K990964
Methodology: https://510kreport.com/methodology