# K082858: Exsept WC Antimicrobial Skin and Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Alcavis International, Inc.
- Decided: May 27, 2009 after 240 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 K914579 (1992). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061467: Exsept WC Wound Cleanser, Alcavis International, Inc. (2007) Summary page 1.
- K063069: Silvaklenz Skin and Wound Clenser Solution, Medical Molecular Therapuetics, LLC (2007) Summary page 1.
- K042729: Dermacyn Wound Irrigation, Oculus Innovative Sciences, Inc. (2005) Summary page 1.
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 1.

## Indications for use
OTC: ExSept WC Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin. Professional Use: Under supervision of healtheare professionals, ExSept WC Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree bums, grafted and donor sites, and catheter exit sites.

Source page: https://510kreport.com/device/K082858
Methodology: https://510kreport.com/methodology