# K974348: Algoplaque Film Extra Thin Hydrocolloid Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Laboratoires Urgo S.A.
- Decided: Feb 13, 1998 after 86 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
Longest line of descent: 1 generation back to K840438 (1984). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970518: Algoplaque Hydrocolloid Dressing, Laboratoires Urgo S.A. (1997) Summary page 2.
- K925990: Duoderm Extra Thin CGF Dressing, Convatec, A Division of E.R. Squibb & Sons (1993) Summary page 2.
- K840438: Comfeel Ulcus Sheet, Coloplast A/S (1984) Summary page 2.

## Most influential descendants
- K082208: Doctors Choice Slow Healing Bandage with Spray on Remover (2008), 0 descendants of its own

## Indications for use
Algoplaque Film Extra Thin Hydrocolloid Dressings are intended for the local management of superficial, dry to lightly-exudating wounds, including superficial burns, pressure sores, dermal ulcers, post-operative wounds or suture sites, abrasions and lacerations. Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as protective skin coverings. Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on third degree burns.

Source page: https://510kreport.com/device/K974348
Methodology: https://510kreport.com/methodology