# K023487: Histofreezer Wart Removal System or Other Proprietary Name

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Mar 20, 2003 after 154 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911420 (1991). 4 ancestors in all.
22 later devices descend from it; 7 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911420: Histofreezer, Solarcare Technologies Corp,Inc. (1991) Summary page 1.
- K924114: Histofreezer, Solarcare Technologies Corp,Inc. (1993) Summary page 1.
- K971392: Histofreezer Verruca Plana, OraSure Technologies, Inc. (1997) Summary page 1.
- K011708: Modification to Wartner Wart Removal System, Wartner Medical Products (2002)
- (no number) Compound W Gel: named in the summary without a submission number
- (no number) Clear Away Liquid: named in the summary without a submission number
- (no number) Clear Away One Step for Kids: named in the summary without a submission number
- (no number) Rite Aid Wart Liquid: named in the summary without a submission number

## Most influential descendants
- K031697: DR. Scholl's Freeze Away Wart Remover, Model 40226 (2003), 11 descendants of its own
- K101049: Wart Freeze (2011), 10 descendants of its own
- K130599: Wart Freeze (2013), 9 descendants of its own
- K211099: Freeze’n Clear Skin Clinic Warts & Tags (2022), 8 descendants of its own
- K140314: Wartie Wart Remover (2014), 8 descendants of its own

## Recalls of this device
- Jul 15, 2020 · Class III · Z-3002-2020: Unit boxes not properly sealed
- Jul 15, 2020 · Class III · Z-3003-2020: Unit boxes not properly sealed
- Jul 15, 2020 · Class III · Z-3001-2020: Unit boxes not properly sealed

## Indications for use
The Histofreezer® Wart Removal System is indicated for over-the-counter treatment of common and plantar warts.

Source page: https://510kreport.com/device/K023487
Methodology: https://510kreport.com/methodology