# K253665: Vashe Plus Antimicrobial Solution

- Pathway: 510(k) (Traditional)
- Applicant: Urgo Medical North America, LLC
- Decided: Aug 11, 2026 after 263 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: 10 generations back to K914579 (1992). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ), Puricore, Inc. (2014) Summary page 5.

## Indications for use
Under the supervision of healthcare professional, Vashe Plus Antimicrobial Solution is intended for cleansing, irrigating, debridement (slough removal), moistening, and removal of foreign material including microorganisms and debris from exudating and/or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, first and second degree burns, post-surgical, abrasions, minor irritations of the skin, diabetic foot ulcers, grafted and donor sites, and exit sites (ports). Moistening and lubricating absorbent wound dressings.

Source page: https://510kreport.com/device/K253665
Methodology: https://510kreport.com/methodology