Microwave Ablation Device Exceed S10U; Sterile Microwave Ablation Probe Exact
by Hygea Medical Technology Co., Ltd. China(FDA 510(k) applicant) EUDAMED510(k)
510(k) K233140 Product code NEY
Overview
The Microwave Ablation Device Exceed S10U is a System, Ablation, Microwave And Accessories, designed to deliver controlled microwave energy for tissue ablation. It employs a sterile microwave ablation probe (Exact) to generate thermal energy, enabling precise destruction of targeted tissue under medical supervision.
This device is intended for use in clinical settings by qualified healthcare professionals, adhering to manufacturer-provided instructions. Supplied sterile, it is classified as a Class II medical device under FDA regulation 878.4400 and has received FDA 510K clearance and MDR authorization. The system includes multiple probe references for compatibility with various ablation procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK233140 | Date31 Jan 2024 | 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- Withdrawn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
- NEY
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- 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 Microwave Ablation Device (Exceed S10U) designed to support, and how does it ensure precision in tissue ablation?
The Microwave Ablation Device (Exceed S10U) is designed to deliver controlled microwave energy for tissue ablation under medical supervision, primarily supporting procedures in general and plastic surgery. Its precision comes from the sterile microwave ablation probe (Exact), which generates thermal energy to target and destroy specific tissue areas as directed by the manufacturer’s instructions. The system includes multiple probe references to accommodate various ablation needs, ensuring adaptability for different clinical scenarios.
Is the Microwave Ablation Probe (Exact) single-use or reusable, and how should it be handled to maintain sterility?
The Microwave Ablation Probe (Exact) is supplied sterile and is intended for single-use only. Since it is sterile at the time of supply, it should be handled using aseptic techniques to prevent contamination. Once used, it must be disposed of according to medical waste protocols to avoid reuse, ensuring patient safety and compliance with sterile field requirements.
What regulatory pathways has the Microwave Ablation Device (Exceed S10U) followed, and what does this mean for its use in clinical settings?
The device has undergone FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for safety and effectiveness. This means it has been evaluated by the FDA as substantially equivalent to a predicate device and aligns with EU medical device regulations. Clinicians can rely on its compliance with these pathways, ensuring it adheres to strict manufacturing, performance, and labeling requirements for use in clinical ablation procedures.
How many probe models are compatible with the Exceed S10U system, and what does this flexibility allow for in clinical applications?
The system supports multiple probe references, as indicated by the listed FEI numbers (e.g., 1000523114, 1721676, etc.), which correspond to different probe configurations. This flexibility allows clinicians to select the appropriate probe length, diameter, or antenna design based on the specific ablation target—whether for superficial or deeper tissue—enhancing versatility in procedures like tumor removal or benign lesion treatment.
What storage conditions should be followed for the Microwave Ablation Device (Exceed S10U) to ensure its performance and sterility?
While specific storage conditions aren’t detailed in the data, as a sterile, single-use device, it should be stored in its original packaging in a clean, dry environment protected from extreme temperatures, moisture, or direct sunlight. The packaging should remain intact until immediate use to preserve sterility and functionality. Always follow the manufacturer’s instructions for storage to maintain device integrity.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K233140
- EUDAMED