HYGEA

GUDID 06935650603100

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.

Hygea Medical Technology Co., Ltd.

General cryosurgical system, cryogen gas, electronic

• Primary Device ID: 06935650603100
• NIH Device Record Key: a17bb89a-8fbd-4f38-91c5-6e4caa79f634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYGEA
• Version Model Number: Elite RBX26
• Company DUNS: 549765730
• Company Name: Hygea Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06935650603100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243042

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-16
• Device Publish Date: 2025-09-08

On-Brand Devices [HYGEA]

• 06935650603209: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650626468: The Sterile Temperature Probe is intended to be used in conjunction with the Exceed S10U microwa
• 06935650626451: The Sterile Temperature Probe is intended to be used in conjunction with the Exceed S10U microwa
• 06935650626048: The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare
• 06935650624327: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650623351: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650623344: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650622729: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650622699: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650622682: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650622668: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650622651: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650622637: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650622620: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650622613: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650621371: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650621357: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650621333: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650621319: Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for
• 06935650603254: The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, inten
• 06935650603247: The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, inten
• 06935650603230: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603223: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603216: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603193: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603186: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603179: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603162: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603155: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603148: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603131: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603124: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603117: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603100: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603094: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603087: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603070: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603063: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603056: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650603049: The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to d
• 06935650602073: The Sterile Temperature Probe is intended to be used in conjunction with the Co-Ablation System
• 06935650602066: The Sterile Temperature Probe is intended to be used in conjunction with the Co-Ablation System
• 06935650602059: The Sterile Temperature Probe is intended to be used in conjunction with the Co-Ablation System
• 06935650602042: The Sterile Temperature Probe is intended to be used in conjunction with the Co-Ablation System