# K053436: Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console

- Pathway: 510(k) (Special)
- Applicant: Cryocath Technologies, Inc.
- Decided: Jan 13, 2006 after 35 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K942299 (1995). 43 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 66 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.
- K011040: Cryocare Cardiac Surgical System, Endocare, Inc. (2001) Summary page 1.
- K973190: Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 Series, Cryomedical Sciences, Inc. (1997) Summary page 1.
- K023288: Cobra Bipolar Clamp, Model 15902, Boston Scientific EP Technologies (2003) Summary page 1.
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1, AtriCure, Inc. (2002) Summary page 1.
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880, Medtronic Vascular (2002) Summary page 1.

## Most influential descendants
- K082074: Atricure CRYO1 Cryo-Ablation Probe (2009), 16 descendants of its own
- K111042: Atricure Cryo Module (2011), 14 descendants of its own
- K112072: Atricure Cryo Module System (2011), 13 descendants of its own
- K121507: Atricure Cryo Module System (Acm, CRYO1, and Cryoice) (2012), 11 descendants of its own
- K140058: Atricure Cryo Module System (2014), 10 descendants of its own

## Recalls of this device
- May 5, 2006 · Not classified · Z-0079-2007: Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expirata

## Indications for use
The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 6cm, 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp 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/K053436
Methodology: https://510kreport.com/methodology