# K971392: Histofreezer Verruca Plana

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Oct 21, 1997 after 189 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.
23 later devices descend from it; 2 cite it directly.
0 of 24 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
- K023487: Histofreezer Wart Removal System or Other Proprietary Name (2003), 22 descendants of its own
- 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

## 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/K971392
Methodology: https://510kreport.com/methodology