# K990877: Histofreezer Device

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Jun 14, 1999 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 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
- K161337: CryoDose H or Similar (2016), 3 descendants of its own
- K233347: Verruca-Freeze® H (2023), 2 descendants of its own
- K243454: Verruca-Freeze H (2024), 1 descendant of its own
- K252903: Verruca-Freeze H Plus (2025), 0 descendants of its own
- K152203: Utermohlen Cryo Professional (2015), 0 descendants of its own

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

Source page: https://510kreport.com/device/K990877
Methodology: https://510kreport.com/methodology