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510(k) Data Aggregation

    K Number
    K231661
    Device Name
    CryoThin™ Surgical System and Accessories
    Date Cleared
    2023-11-27

    (173 days)

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

    Medinux (Tianjin) Technologies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CryoThin™ Surgical System is intended for cryosurgery in the fields of general surgery, urology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastase, tumors, skin lesions, and warts. The system has the following specific 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, 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 cancerous lesions
    Device Description
    Cryosurgery is the use of ultra-low temperatures for selectively freezing and destroying diseased tissues in situ. The CryoThin™ Surgical System is designed to ablate benign and malignant tissues using cryosurgery. The system utilizes the Joule-Thomson effect for freezing. It uses high-pressure argon gas that undergoes throttling expansion to induce freezing inside the closed tip of the Cryo probe to freeze the target tissue around the probe tip. Low-pressure argon is electrically heated and blown into the probe tip to thaw the tissue around it. The CryoThin Surgical System consists of a console, a cart, and accessories. The system must be used in conjunction with the Cryo probes for freeze and thaw functions, and the Temp probes for monitoring the temperature in target or adjacent tissues.
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