# K980739: Histofreezer/ 17% Salicylic Acid-Verruca Plantaris

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: May 26, 1998 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052259: DR. Scholl's Dual Action Freeze Away Wart Remover, Model 40406 (2005), 1 descendant of its own
- K161294: Compound W Wart Removal System Dual Power (2016), 0 descendants of its own

## Indications for use
Histofreezer is indicated for use in the treatment of the following: Genital Warts Molluscum Contagiosum Seborrhoeic Keratosis Skin Tags Verruca Plantaris Verruca Vulgaris Verruca Plana

Source page: https://510kreport.com/device/K980739
Methodology: https://510kreport.com/methodology