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510(k) Data Aggregation

    K Number
    K151968
    Device Name
    Cryocare CS-3 Surgical System version 5
    Manufacturer
    HEALTHTRONICS
    Date Cleared
    2015-09-09

    (55 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHTRONICS

    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, 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 hemangiomas, mucocele cysts, multiple 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
    K141110
    Device Name
    CRYOCARE CS SURGICAL SYSTEM
    Manufacturer
    HEALTHTRONICS
    Date Cleared
    2015-06-25

    (422 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHTRONICS

    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, oncology, oncology, 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 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
    K021775
    Device Name
    LTFS230
    Manufacturer
    HEALTHTRONICS, INC.
    Date Cleared
    2002-12-23

    (208 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHTRONICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.
    Device Description
    The LithoDiamond is an Extracorporeal Shock Wave Lithotripter. The primary difference in the devices is that the LithoDiamond has a new imaging system.
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