# K060279: Cryocare CS Surgical System

- Pathway: 510(k) (Special)
- Applicant: Endocare, Inc.
- Decided: Feb 28, 2006 after 26 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K926514 (1993). 17 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050347: Modification to Cryocare CS Surgical System, Endocare, Inc. (2005) Summary page 1.

## Most influential descendants
- K101333: Cryocare CS Surgical System (2010), 8 descendants of its own
- K141110: Cryocare CS Surgical System (2015), 7 descendants of its own
- K151968: Cryocare CS-3 Surgical System version 5 (2015), 6 descendants of its own
- K153489: Cryocare CS Surgical System (2016), 5 descendants of its own
- K201588: CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice (2020), 4 descendants of its own

## Recalls of this device
- Nov 4, 2010 · Not classified · Z-0615-2011: Mislabeled : The label on the outer box and inner pouch of the EndoCare 2.4mm CryoProbe (CRYO-44F) inaccurately reference the CVA2400 (2.4mm Variable Probe aka: V-Probe).
- Dec 5, 2008 · Not classified · Z-1401-2010: Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes 
- Dec 5, 2008 · Not classified · Z-1400-2010: Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes 

## Indications for use
The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications: General Surgery * Destruction of warts or lesions * Palliation of tumors of the oral cavity, rectum and skin * Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions

Source page: https://510kreport.com/device/K060279
Methodology: https://510kreport.com/methodology