# K103713: Elta Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Swiss American Products, Inc.
- Decided: Jun 16, 2011 after 177 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K243166: Dermalage (2025), 0 descendants of its own

## Indications for use
Elta Wound Cleanser is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.

Source page: https://510kreport.com/device/K103713
Methodology: https://510kreport.com/methodology