# K062140: Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1

- Pathway: 510(k) (Special)
- Applicant: Cryocath Technologies, Inc.
- Decided: Aug 24, 2006 after 28 days
- Product code: OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942299 (1995). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021010: Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE, Endocare, Inc. (2002) Summary page 1.
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console, Cryocath Technologies, Inc. (2004) Summary page 1.
- K053436: Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console, Cryocath Technologies, Inc. (2006) Summary page 1.
- K011040: Cryocare Cardiac Surgical System, Endocare, Inc. (2001)
- K973190: Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 Series, Cryomedical Sciences, Inc. (1997) Summary page 1.

## Most influential descendants
- K070947: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist Cardiac Probe Grasper (2008), 0 descendants of its own

## Indications for use
The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Source page: https://510kreport.com/device/K062140
Methodology: https://510kreport.com/methodology