# K073019: Silvermed Antimicrobial Silver Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Argentis Biomedical Incorporated
- Decided: Sep 16, 2008 after 327 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: 5 generations back to K973688 (1997). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932291: Eutra Gel for Wound Dressing, Swiss American Products, Inc. (1994) Summary page 1.
- K011994: Acryderm Silver Anttimicrobial Wound Gel Model# a-002101, Acrymed, Inc. (2001)
- K062212: Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S, Anacapa Technologies, Inc. (2006) Summary page 1.
- K061227: Hydrolyzed Collagen/AG Wound Gel with Silver, The Hymed Group Corp. (2006) Summary page 1.
- K071703: Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic, Swiss American Products, Inc. (2007) Summary page 1.

## Most influential descendants
- K132891: Hydrolyzed Collagen/AG Wound Gel with Silver (2014), 0 descendants of its own

## Indications for use
SilverMedTM Antimicrobial Hydrogel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.

Source page: https://510kreport.com/device/K073019
Methodology: https://510kreport.com/methodology