# K063805: Silcryst Silver Antimicrobial Wound Cream, Model a-00901

- Pathway: 510(k) (Traditional)
- Applicant: Nucryst Pharmaceuticals, Inc.
- Decided: Jul 13, 2007 after 203 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: 6 generations back to K945802 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042352: Bioderm Sciences Wound Cream, Bioderm Sciences, Inc. (2005) Summary page 1.
- K011994: Acryderm Silver Anttimicrobial Wound Gel Model# a-002101, Acrymed, Inc. (2001) Summary page 1.
- K955453: Acticoat Silver Coated Dressing, Westaim Technologies, Inc. (1996) Summary page 1.

## Indications for use
Sileryst® Silver Antimicrobial Wound Cream is intended for external management of partial and full-thickness wounds including decubitus ulcers, venous'stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, cuts, donor sites and surgical wounds.

Source page: https://510kreport.com/device/K063805
Methodology: https://510kreport.com/methodology