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510(k) Data Aggregation
K Number
K243042Device Name
Co-Ablation System with Sterile Co-Ablation Probe
Manufacturer
Hygea Medical Technology Co., Ltd.
Date Cleared
2025-01-29
(124 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
Hygea Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, intended for use in open. minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-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 also 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 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 and rectum.
- · Ablation of hemorrhoids.
Thoracic Surgery
- · Ablation of cancerous lesions.
Device Description
The Co-Ablation System with Sterile Co-Ablation Probe is a device designed to freeze/ablate tissue. It utilizes phase change effect to generate extremely low temperature and high temperature to destroy lesion tissues with a combined working mode, to achieve better clinical efficacy, safety and efficiency.
Main components: Co-Ablation System, Sterile Co-Ablation Probe. Accessory: Sterile Temperature Probe.
The Co-Ablation System is a mobile medical equipment. The Co-Ablation System consists a host of Co-Ablation System including liquid nitrogen storage tank (referred to as cryotank), cryo-valve, warm working medium storage tank (referred to as warmtank), warm-valve, waste bottle,insulated pipe and control/display system, etc. The Co-Ablation System has model number with AI Epic S40U and AI Epic S20U.
The Sterile Co-Ablation Probe is a single-use sterile product, consisting of a handle, quick release connector, probe tip and probe shaft. It must be used in conjunction with the Co-Ablation System. During treatment, the Sterile Co-Ablation Probe is inserted into the lesion to be ablated. The freezing channel is opened, and the freeze working medium (liquid nitrogen) rapidly flows to the probe and evaporates to absorb heat, rapidly freezing and destroying tissue near the probe tip. When the system is switched from the freeze mode to warm mode, high temperature steam passes to the tip of the Sterile Co-Ablation Probe, rapidly heating the tip portion of the Sterile Co-Ablation Probe so that the frozen tissue around the Sterile Co-Ablation Probe is quickly melted, and the Sterile Co-Ablation Probe is easily pulled out. The Sterile Co-Ablation Probe consists of right-angle and straight configurations with model number Elite, and comprises 20 specifications as listed below:
| Model | Specifications | Structural Form |
|-------|----------------|---------------------|
| Elite | ACL17 | Straight shaped |
| | ACS17 | |
| | ACX17 | |
| | ABL20 | Right-angled shaped |
| | ABS20 | |
| | ABX20 | |
| | ADL26 | |
| | RCL17 | |
| | RCS17 | |
| | RCX17 | |
| | RBL20 | |
| | RBS20 | |
| | RBX20 | |
| | RBL26 | |
| | RBS26 | |
| | RBX26 | |
| | RAL26 | |
| | RAS26 | |
| | RAL30 | |
| | RAS30 | |
The Sterile Temperature Probe is designed for use with the Co-Ablation System to monitor temperatures in the surrounding tissue. The Sterile Temperature Probe with model number Ease, and comprises 4 specifications: TSS08, TSL08, TMS15 and TML15.
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K Number
K233140Device Name
Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
Manufacturer
Hygea Medical Technology Co., Ltd.
Date Cleared
2024-01-31
(126 days)
Product Code
NEY
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Hygea Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use.
Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.
Device Description
The Microwave Ablation Device with Sterile Microwave Ablation Probe is a device system which is intended for soft tissue coagulation. The Microwave Ablation Device consists of power supply, microwave power source, control system, temperature measurement system, RF connection cable, foot switch, and temperature probe. The Sterile Microwave Ablation Probe is a single-use sterile product, consisting of a handle, RF connector, RF coaxial cable, needle bar, inner tube, pinhead, temperature sensor and coolant tube. The Microwave Ablation Device also contains a single use Sterile Temperature Probe.
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