# K090345: Mendasil TWG Gel Antimicrobial Skin and Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Conseal International, Inc.
- Decided: Jan 7, 2010 after 331 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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)
- K062212: Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S, Anacapa Technologies, Inc. (2006) Summary page 1.

## Indications for use
MendaSilTM-TWG Gel Skin and Wound Gel is indicated for use under the supervision of a healthcare professional for management of partial to full thickness wounds from mild to moderate exudate such as Stage I-IV Pressure Ulcers, Partial and Full Thickness Wounds, 1st and 2nd Degree Burns, Diabetic Foot Ulcers, Venous Stasis Ulcers and surgical Incision Wounds. The Gel can also be used for management of minor cuts, scrapes/abrasions, and irritated skin.

Source page: https://510kreport.com/device/K090345
Methodology: https://510kreport.com/methodology