# K201366: Forwarts

- Pathway: 510(k) (Traditional)
- Applicant: Pronova Laboratories BV
- Decided: Jan 21, 2021 after 244 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: 6 generations back to K911420 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130599: Wart Freeze, Koninklijke Utermohlen NV (2013) Summary page 5.
- K172373: Compound W Nitro-Freeze, Medtech Products, Inc. (2017) Summary page 5.
- K140314: Wartie Wart Remover, Yonmedical BV (2014) Summary page 5.
- K032271: Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022), Wartner USA B.V. (2003) Summary page 5.

## Indications for use
Forwarts® is indicated for the treatment of warts on hands (common warts) and feet (plantar warts).

Source page: https://510kreport.com/device/K201366
Methodology: https://510kreport.com/methodology