Identity
- Trade Name
- HYGEA FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, electronic FDA UDI
- Device Name
- The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to destroy solid tumors, intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, 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. FDA UDI
- Model / Reference
- Elite RCL17 FDA UDI
- Description
- The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to destroy solid tumors, intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06935650603148 FDA UDI
- 510(k) Number
- K243042 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- General cryosurgical system, cryogen gas, electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: General cryosurgical system, cryogen gas, electronic
Hygea by Hygea Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K243042 also covers:
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
- HYGEA — Hygea Medical Technology Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hygea Medical Technology Co., Ltd.
Sources (1)
- FDA UDI 9ac2a0d8-8dad-43ef-bc3d-d14e13ab494a 34 fields · synced May 30, 2026