# K061467: Exsept WC Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Alcavis International, Inc.
- Decided: Feb 15, 2007 after 265 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: 4 generations back to K945802 (1995). 5 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965120: Allclenz Wound Cleanser, Dpt Laboratories, Ltd. (1997) Summary page 1.
- K022670: Carraklenz and Ultraklenz, Carrington Laboratories, Inc. (2002) Summary page 1.
- K042729: Dermacyn Wound Irrigation, Oculus Innovative Sciences, Inc. (2005) Summary page 1.

## Most influential descendants
- K111313: Exsept Skin and Wound Cleanser with Antimicrobial Preservative (2011), 9 descendants of its own
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) (2014), 8 descendants of its own
- K141012: Hydrocleanse Wound Care Solution (2014), 4 descendants of its own
- K161034: Microcyn Plus Wound Care Solution (2016), 3 descendants of its own
- K243415: Granudacyn® Wound Irrigation Solution (2025), 1 descendant of its own

## Indications for use
For debridement and the removal of foreign material and debris from exudating and/or dirty wounds, abrasions and minor irritations, cuts, exit sites, and intact skin.

Source page: https://510kreport.com/device/K061467
Methodology: https://510kreport.com/methodology