# K073197: Silver Antimicrobial Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions Limited
- Decided: Aug 28, 2008 after 289 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: 2 generations back to K011994 (2001). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062212: Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S, Anacapa Technologies, Inc. (2006) Summary page 1.
- K011994: Acryderm Silver Anttimicrobial Wound Gel Model# a-002101, Acrymed, Inc. (2001)
- K070333: Acryderm Silver Antimicrobial Otc Wound Gel, Acrymed, Inc. (2007) Summary page 1.

## Most influential descendants
- K110458: Silver Antimicrobial Wound Gel (2011), 1 descendant of its own
- K152519: MTR550 (Tentative) Antimicrobial Silver Wound Gel (2016), 0 descendants of its own

## Indications for use
Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial to full thickness wounds, such as: * Pressure Ulcers * Leg Ulcers * Diabetic Ulcers * Graft and donor sites * Post-operative surgical wounds * Trauma wounds (dermal lesions, trauma injuries or incisions) * I" and 2 nd degree bums * Abrasions and lacerations

Source page: https://510kreport.com/device/K073197
Methodology: https://510kreport.com/methodology