# K152203: Utermohlen Cryo Professional

- Pathway: 510(k) (Traditional)
- Applicant: Koninklijke (Royal) Utermohlen
- Decided: Nov 6, 2015 after 92 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: 1 generation back to K982358 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982358: Histofreezer Device, OraSure Technologies, Inc. (1998) Summary page 4.
- K990877: Histofreezer Device, OraSure Technologies, Inc. (1999) Summary page 4.
- K982506: Verruca-Freeze Cryosurgery Delivery System, Cryosurgery, Inc. (1999) Summary page 4.

## Indications for use
The product is indicated for the removal of the following skin lesions: - Verrucae plantaris - Verrucae Plana - Verrucae vulgaris - Mollescum contagiosum - Skin tags - Actinic keratosis - Genital warts - Lentigo - Seborrhoeic Keratosis

Source page: https://510kreport.com/device/K152203
Methodology: https://510kreport.com/methodology