# K161294: Compound W Wart Removal System Dual Power

- Pathway: 510(k) (Traditional)
- Applicant: Medtech Products, Inc.
- Decided: Sep 15, 2016 after 129 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- 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 K911420 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052259: DR. Scholl's Dual Action Freeze Away Wart Remover, Model 40406, Schering-Plough Healthcare Products, Inc. (2005) Summary page 5.

## Indications for use
For the over-the-counter removal of common and plantar warts.

Source page: https://510kreport.com/device/K161294
Methodology: https://510kreport.com/methodology