# K070893: Cryospray Ablation System, Model CU 8407020500

- Pathway: 510(k) (Special)
- Applicant: CSA Medical, Inc.
- Decided: May 1, 2007 after 32 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: 4 generations back to K840536 (1984). 8 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060555: Spraygenix Cryo Ablation System, Crymed Technologies, Inc. (2006) Summary page 1.

## 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 CryoSpray AblationTM System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Source page: https://510kreport.com/device/K070893
Methodology: https://510kreport.com/methodology