# K982280: Cryopro Maxi and Cryopro Mini

- Pathway: 510(k) (Traditional)
- Applicant: Cortex Technology Aps
- Decided: Nov 25, 1998 after 148 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.
18 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CryoGun® liquid nitrogen cryosurgical system: named in the summary without a submission number

## Most influential descendants
- K040809: Crymed Cryo-Ablator (2004), 16 descendants of its own
- K060555: Spraygenix Cryo Ablation System (2006), 15 descendants of its own
- K070893: Cryospray Ablation System, Model CU 8407020500 (2007), 13 descendants of its own
- K101825: Cryoballoon Ablation System (2010), 11 descendants of its own
- K131523: Cryoballoon Focal Ablation System (2013), 10 descendants of its own

## Indications for use
The CryoPro® Mini and CryoPro® Maxi units are intended to be used within the fields of dermatology and plastic surgery for the treatment of cryoresponsive benign, premalignant and malignant tumors such as skin tags, verrucae, actinic keratoses and basal cell carcinoma.

Source page: https://510kreport.com/device/K982280
Methodology: https://510kreport.com/methodology