# K220759: Armis VeriCyn Wound Wash

- Pathway: 510(k) (Traditional)
- Applicant: Armis Biopharma, Inc.
- Decided: May 25, 2023 after 436 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945802 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161165: Next Science Irrigation Solution, Next Science, LLC (2016) Summary page 4.

## Indications for use
The Armis VeriCyn® Wound Wash is to be used with a lavage system to create mechanical movement at the wound surface by delivery of a solution and is indicated for use in cleansing and removal of foreign material including micro-organisms and debris from wounds (such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first degree and partial thickness burns, grafted and donor sites).

Source page: https://510kreport.com/device/K220759
Methodology: https://510kreport.com/methodology