# K021387: Polar Wand

- Pathway: 510(k) (Traditional)
- Applicant: Chek-Med Systems
- Decided: Jul 31, 2002 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.
12 later devices descend from it; 1 cites it directly.
0 of 13 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
- K101825: Cryoballoon Ablation System (2010), 11 descendants of its own
- K131523: Cryoballoon Focal Ablation System (2013), 10 descendants of its own
- K151054: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System (2015), 8 descendants of its own
- K152329: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System (2016), 6 descendants of its own
- K161202: C2 Cryoballoon Ablation System (2017), 5 descendants of its own

## Indications for use
The Polar Wand Cryotherapy System is used for ablation of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and gastroenterology. The system may be used with a variety of cryogens, e.g. carbon dioxide, nitrous oxide, argon, krypton.

Source page: https://510kreport.com/device/K021387
Methodology: https://510kreport.com/methodology