# K011618: Calgitrol AG Silver Alginate Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Adri
- Decided: Nov 15, 2002 after 539 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 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
- K041268: Silversite or Calgitrol (2004), 2 descendants of its own
- K053590: Silverlon  CA (Calcium Alginate) (2006), 1 descendant of its own
- K192478: LT Antibacterial Alginate with Silver Dressing (2020), 0 descendants of its own
- K173072: Algidex Ag Silver Alginate Wound  Dressing (2018), 0 descendants of its own
- K142962: PROTOCOL Incision Dressing (2015), 0 descendants of its own

## Indications for use
Pressure ulcers, Srages I-ZV Dermal lesions (or secreting skin injuries) Venous ulcers, Srasis ulcers l H and 2"6degree burns; donor sites

Source page: https://510kreport.com/device/K011618
Methodology: https://510kreport.com/methodology