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510(k) Data Aggregation
K Number
K153489Device Name
Cryocare CS Surgical System
Manufacturer
Health Tronics
Date Cleared
2016-02-05
(63 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
Health Tronics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 breast fibroadenomas
- Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, 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
Device Description
The Endocare™ Cryocare CS® Surgical System is a mobile console system intended for cryoablative tissue destruction. The system consists of a compact, easy to operate console and associated accessories that include cryoprobes to deliver cold temperatures to the targeted tissue, and TempProbe® devices to monitor temperatures in the surrounding tissue.
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K Number
K012785Device Name
TWINTRODE ELC 134 ELECTRODE
Manufacturer
HEALTH TRONICS SURGICAL SERVICES, INC.
Date Cleared
2001-11-16
(88 days)
Product Code
LNS
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
HEALTH TRONICS SURGICAL SERVICES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TwinTrode® ELC 134 Electrode, is intended for multiple patient use during lithotripsy procedures as a replacement electrode to be used with the LithoTron Lithotripsy System.
Device Description
The TwinTrode® ELC 134 Electrode is a multiple patient use electrode for electrohydraulic extracorporeal shock wave lithotripter. It is substantially equivalent to the NewTrode® ELC 124 Both electrodes are components of the HealthTronics LithoTron Electrode (predicate device). Lithotripsy System. The TwinTrode and NewTrode devices are very similar and are utilized as part of the LithoTron The TwinTrode differs from the NewTrode in that the longevity of the system identically. TwinTrode is up to 2.5 times greater than the longevity of the NewTrode.
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