# K052536: Algicell AG

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences Canada, Inc.
- Decided: Sep 13, 2006 after 363 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080497: Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver (Algicell AG) (2008), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, AlgicelleAg dressing is an effective barrier to bacterial penetration in moderate to heavily exuding wounds such as diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology), pressure ulcers/sores (partial and full thickness), donor sites, and traumatic and surgical wounds.

Source page: https://510kreport.com/device/K052536
Methodology: https://510kreport.com/methodology