# K101333: Cryocare CS Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Jun 14, 2010 after 33 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: 7 generations back to K926514 (1993). 18 ancestors in all.
8 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)
- K060279: Cryocare CS Surgical System, Endocare, Inc. (2006) Summary page 1.
- K043278: Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes, Teratech Corp. (2004) Summary page 3.

## Most influential descendants
- 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
- K230271: ISOLIS Cryoprobe (2023), 1 descendant of its own

## Recalls of this device
- Dec 20, 2012 · Class II · Z-0825-2013: The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
- Feb 27, 2012 · Not classified · Z-1275-2012: HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label nea

## Indications for use
The Oryocare CS Surgical System is intended for use in open, minimally invasive or endloscopic 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 wadts. In addition, the system is intended for use in the following indications: General Surger * 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 hemnanglomnas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomnata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomnas, 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/crycanalgesia 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 Sur-ger * Ablation of arrhythmic cardiac tissue * Ablation of cancerous lesions

Source page: https://510kreport.com/device/K101333
Methodology: https://510kreport.com/methodology