# K023757: Cryocare Surgical System, Model Cryo 20

- Pathway: 510(k) (Special)
- Applicant: Endocare, Inc.
- Decided: Dec 5, 2002 after 27 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011074 (2002). 1 ancestor in all.
54 later devices descend from it; 2 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011074: Cryocare Surgical System, Endocare, Inc. (2002)

## Most influential descendants
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140 (2010), 39 descendants of its own
- K113237: Certus 140 2.45GHZ Ablation System (2012), 38 descendants of its own
- K133821: Emprint Ablation System (2014), 29 descendants of its own
- K163105: Emprint Ablation System (2016), 13 descendants of its own
- K032333: Cryocare CS Surgical System (2003), 13 descendants of its own

## Recalls of this device
- 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 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 freezeiablate 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 leukoplaha 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 Urology Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia Oncology Ablation of cancerous or malignant tissue Ablation of benign tumors Palliative intervention Neurology Freezing of nerve tissue in pain managementlcryoanalgesia Dermatology Ablation or freezing of skin cancers and other cutaneous disorders Proctology Ablation of benign or malignant growths of the anus or rectum Ablation of hemorrhoids Thoracic SurPery Ablation of arrhythmic cardiac tissue Ablation of cancerous lesions

Source page: https://510kreport.com/device/K023757
Methodology: https://510kreport.com/methodology