# K060859: Compound W Freeze Off Wart Removal System

- Pathway: 510(k) (Special)
- Applicant: OraSure Technologies, Inc.
- Decided: Jul 18, 2006 after 112 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: 2 generations back to K911420 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023487: Histofreezer Wart Removal System or Other Proprietary Name, OraSure Technologies, Inc. (2003) Summary page 1.
- K011708: Modification to Wartner Wart Removal System, Wartner Medical Products (2002) Summary page 1.

## Indications for use
The Compound W® Freeze Off TM Plantar Wart Removal System is indicated for over-the-counter treatment of common and plantar warts.

Source page: https://510kreport.com/device/K060859
Methodology: https://510kreport.com/methodology