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510(k) Data Aggregation
K Number
K151968Device Name
Cryocare CS-3 Surgical System version 5
Manufacturer
HEALTHTRONICS
Date Cleared
2015-09-09
(55 days)
Product Code
GEH
Regulation Number
878.4350Why 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
K141110Device Name
CRYOCARE CS SURGICAL SYSTEM
Manufacturer
HEALTHTRONICS
Date Cleared
2015-06-25
(422 days)
Product Code
GEH
Regulation Number
878.4350Why 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
K021775Device Name
LTFS230
Manufacturer
HEALTHTRONICS, INC.
Date Cleared
2002-12-23
(208 days)
Product Code
LNS
Regulation Number
876.5990Why 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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