# K041268: Silversite or Calgitrol

- Pathway: 510(k) (Traditional)
- Applicant: Adri
- Decided: Sep 20, 2004 after 131 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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: 2 generations back to K970566 (1997). 4 ancestors in all.
2 later devices descend from it; 2 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)
- K011618: Calgitrol AG Silver Alginate Wound Dressing, Adri (2002) Summary page 3.
- K970566: Arglaes Film Dressing, Maersk Medical, Ltd. (1997) Summary page 2.
- K990810: Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing, Maersk Medical, Ltd. (1999) Summary page 2.

## Most influential descendants
- K173072: Algidex Ag Silver Alginate Wound  Dressing (2018), 0 descendants of its own
- K102212: D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix Silver (2011), 0 descendants of its own

## Indications for use
Pressure ulccrs,.Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Staiis ulcers Intended to protect vascular access sites, intramuscular sites. and surgical incisions 1" and 2t degree bums Donor sites

Source page: https://510kreport.com/device/K041268
Methodology: https://510kreport.com/methodology