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510(k) Data Aggregation
K Number
K231661Device Name
CryoThin Surgical System and Accessories
Manufacturer
Date Cleared
2023-11-27
(173 days)
Product Code
Regulation Number
878.4350Why 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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