Co-Ablation System with Sterile Co-Ablation Probe
by Hygea Medical Technology Co., Ltd. China(FDA 510(k) applicant) EUDAMED510(k)
510(k) K243042 Product code GEH
Overview
The Co-Ablation System with Sterile Co-Ablation Probe is a cryosurgical device designed for controlled tissue ablation. It employs cryotherapy to freeze and destroy targeted tissue, including benign or malignant lesions, through precise temperature regulation and probe application. The system integrates with cryosurgical accessories to enhance procedural accuracy and patient outcomes in general and plastic surgery settings.
This device is supplied as a sterile, single-use system and is intended for use in clinical environments requiring controlled temperature ablation. It operates within Class II regulatory classification and has received FDA 510(k) clearance under the Medical Device Regulation (MDR). The system includes multiple probe references (e.g., 3010242262, 3003678543) and is intended for use in procedures governed by regulatory code 878.4350. Storage and handling must comply with sterile medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK243042 | Date29 Jan 2025 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- GEH
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4350
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Hygea Medical Technology Co., Ltd.
Questions
What types of procedures is the Co-Ablation System primarily used for, and in which clinical settings?
The Co-Ablation System is designed for controlled tissue ablation using cryotherapy, which is particularly useful for treating benign or malignant lesions. It is intended for use in general and plastic surgery settings, where precise temperature regulation is required to freeze and destroy targeted tissue. The system is supplied as a sterile, single-use device, making it suitable for clinical environments where sterile procedures are mandatory.
Is the Co-Ablation System reusable or single-use, and how does this affect its handling and storage?
The Co-Ablation System is explicitly supplied as a sterile, single-use device. This means each system is intended for one-time use only, eliminating the need for reprocessing or sterilization between procedures. Proper storage must adhere to sterile medical device protocols to maintain integrity until use, ensuring no contamination or degradation occurs.
What regulatory pathways has the Co-Ablation System followed, and how does this impact its use in clinical practice?
The Co-Ablation System has received FDA 510(k) clearance and complies with the Medical Device Regulation (MDR). This classification under Class II regulatory standards ensures it meets stringent safety and performance requirements before clinical use. Clinicians can rely on its regulatory approvals when integrating the system into procedures governed by product code 878.4350, which pertains to cryosurgical accessories.
Are there multiple probe models available for the Co-Ablation System, and how do I identify the correct one for my procedure?
Yes, the Co-Ablation System includes multiple probe references, such as 3010242262 and 3003678543, among others. These probes are part of the cryosurgical accessories designed to enhance procedural accuracy. To select the appropriate probe, consult the manufacturer’s documentation or technical specifications, as probe size and design may vary to suit different lesion types or surgical approaches. Always ensure the probe aligns with your intended use case.
How should the Co-Ablation System be stored to maintain its sterility and functionality?
The Co-Ablation System must be stored in accordance with sterile medical device protocols to preserve its integrity. Since it is single-use and sterile upon packaging, it should remain unopened until use. Store the system in a clean, dry environment protected from extreme temperatures, direct sunlight, or physical damage. Follow the manufacturer’s instructions for shelf life and storage conditions to ensure optimal performance and sterility until deployment.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K243042
- EUDAMED