# K032333: Cryocare CS Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Aug 12, 2003 after 14 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: 4 generations back to K926514 (1993). 14 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023757: Cryocare Surgical System, Model Cryo 20, Endocare, Inc. (2002) Summary page 2.
- K002615: Surgical System with Cryoguide, Endocare, Inc. (2000)
- K030191: Terason Model 2000/Bas Portable Ultrasound System, Teratech Corp. (2003)

## Most influential descendants
- K050347: Modification to Cryocare CS Surgical System (2005), 12 descendants of its own
- K060279: Cryocare CS Surgical System (2006), 9 descendants of its own
- 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

## 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 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 management/cryoanalgesia 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 Surgery Ablation of arrhythmic cardiac tissue Ablation of cancerous lesions

Source page: https://510kreport.com/device/K032333
Methodology: https://510kreport.com/methodology