# K151309: Wartie Advanced Wart Remover or other proprietary name

- Pathway: 510(k) (Traditional)
- Applicant: Youmedical Corp BV
- Decided: Aug 14, 2015 after 88 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: 5 generations back to K911420 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140314: Wartie Wart Remover, Yonmedical BV (2014) Summary page 5.
- K023487: Histofreezer Wart Removal System or Other Proprietary Name, OraSure Technologies, Inc. (2003) Summary page 5.

## Indications for use
Wartie® Advanced Wart Remover is indicated for the over-the-counter treatment of common warts and plantar warts for patients ages 12 years and older.

Source page: https://510kreport.com/device/K151309
Methodology: https://510kreport.com/methodology