# K161658: Anexa Wound Flush, Sterile Water & Sterile Normal Saline

- Pathway: 510(k) (Traditional)
- Applicant: Anexa Biomedical, Inc.
- Decided: Sep 14, 2016 after 90 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: 6 generations back to K945802 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083042: Wound Flush, Sterile Water & Normal Saline, Nurse Assist, Inc. (2008) Summary page 4.

## Indications for use
For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.

Source page: https://510kreport.com/device/K161658
Methodology: https://510kreport.com/methodology