# K130599: Wart Freeze

- Pathway: 510(k) (Special)
- Applicant: Koninklijke Utermohlen NV
- Decided: Jun 5, 2013 after 90 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: 3 generations back to K911420 (1991). 6 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101049: Wart Freeze, Koninklijke Utermohlen NV (2011) Summary page 1.

## Most influential descendants
- K140314: Wartie Wart Remover (2014), 8 descendants of its own
- K172373: Compound W Nitro-Freeze (2017), 3 descendants of its own
- K242932: Skin Clinic Nitro Clear Wart Remover (2025), 1 descendant of its own
- K253000: CryoFreeze Wart and Skin Tag Remover (2025), 0 descendants of its own
- K242288: Advanced Cryo Wart Remover (2025), 0 descendants of its own

## Indications for use
The product is indicated for the removal of common and plantar warts.

Source page: https://510kreport.com/device/K130599
Methodology: https://510kreport.com/methodology