# K151185: AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Abl Medical, LLC
- Decided: Feb 5, 2016 after 277 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 K914579 (1992). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063069: Silvaklenz Skin and Wound Clenser Solution, Medical Molecular Therapuetics, LLC (2007) Summary page 4.

## Indications for use
The AGX Wound Wash Skin and Wound Cleanser is indicated for Over the Counter Use - For normal skin and minor wounds, minor burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution. The AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser is Indicated for Prescription Use - To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing solution.

Source page: https://510kreport.com/device/K151185
Methodology: https://510kreport.com/methodology