# K060555: Spraygenix Cryo Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Crymed Technologies, Inc.
- Decided: Apr 21, 2006 after 50 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: 3 generations back to K840536 (1984). 7 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040809: Crymed Cryo-Ablator, Crymed Technologies, Inc. (2004) Summary page 1.
- K813024: WA1000, Wallach Surgical Devices, Inc. (1981) Summary page 1.
- K811390: CCS100 Cryosurgical System, Frigitronics of Connecticut, Inc. (1981) Summary page 1.
- K840536: Cryo Surg 5900, Frigitronics of Connecticut, Inc. (1984) Summary page 1.
- K935010: Wallach Ultra Freeze, Wallach Surgical Devices, Inc. (1994) Summary page 1.
- K982280: Cryopro Maxi and Cryopro Mini, Cortex Technology Aps (1998) Summary page 1.
- K970995: CMS Cryolite, Cryomedical Sciences, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The SprayGeniX TM Cryo Ablation 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/K060555
Methodology: https://510kreport.com/methodology