# K062212: Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S

- Pathway: 510(k) (Traditional)
- Applicant: Anacapa Technologies, Inc.
- Decided: Nov 21, 2006 after 112 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: 1 generation back to K011994 (2001). 1 ancestor in all.
85 later devices descend from it; 8 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011994: Acryderm Silver Anttimicrobial Wound Gel Model# a-002101, Acrymed, Inc. (2001) Summary page 1.

## Most influential descendants
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser (2009), 37 descendants of its own
- K100918: Vashe Wound Therapy System Model: 9000-0014 (2010), 31 descendants of its own
- K123072: Vashe Wound Therapy Solution (2013), 25 descendants of its own
- K101882: Prontosan Antimicrobial Wound Gel (2010), 21 descendants of its own

## Indications for use
Silver ShieldTM Antimicrobial Skin and Wound Gel is intended for OTC use for Abrasions and lacerations and under the supervision of a health care professional in the management of Stage 1-1V Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Grafted and donor sites,

Source page: https://510kreport.com/device/K062212
Methodology: https://510kreport.com/methodology