# K962590: Signaldress

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: Sep 20, 1996 after 80 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) Comfeel Plus Ulcer Dressing: named in the summary without a submission number

## Most influential descendants
- K973717: Combiderm Acd (1997), 0 descendants of its own

## Indications for use
SignaDRESS is intended for chronic wounds-pressure ulcers (Stage I-IV) and leg ulcers. SignaDRESS is also indicated for use on acute wounds-surgical wounds (post-operative wounds and donor sites), traumatic wounds (minor abrasions and lacerations), burns (first and second degree), and dermatological excisions.

Source page: https://510kreport.com/device/K962590
Methodology: https://510kreport.com/methodology