AveCure BT Microwave Ablation System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Avecure Microwave Ablation System EUDAMED
- Device Name
- Avecure Microwave Ablation System EUDAMED
- Model / Reference
- MWAS EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-0858584002MWAS9GFV EUDAMED
- Basic UDI-DI
- B-0858584002MWAS9GFV EUDAMED
- 510(k) Number
- K192406 FDA 510(k)
- FDA Product Code
- NEY FDA 510(k)
- EMDN Code
- K02030199 RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The AveCure BT Microwave Ablation System is a System, Ablation, Microwave and Accessories designed to deliver focused microwave energy for tissue ablation. It employs thermal energy to coagulate and destroy targeted soft tissue, including malignant lesions, through precise microwave application.
This device is intended for percutaneous, laparoscopic, and intraoperative use in coagulation-ablation procedures, including palliative spinal interventions for metastatic lesions. Supplied as a reusable system with sterile applicators, it operates under FDA 510(k) clearance and MDD compliance, adhering to Class II (NEY) regulatory classification. Storage and handling follow manufacturer guidelines to maintain sterility and performance.
Frequently asked questions
What types of procedures is the AveCure BT Microwave Ablation System designed for, and how is it applied?
The AveCure BT Microwave Ablation System is designed for percutaneous, laparoscopic, and intraoperative coagulation-ablation procedures. It delivers focused microwave energy to coagulate and destroy targeted soft tissue, including malignant lesions, through precise application. This makes it suitable for interventions like palliative spinal treatments for metastatic lesions, where controlled thermal energy is needed to ablate tissue.
Is the AveCure BT Microwave Ablation System reusable, and how are the applicators handled?
The AveCure BT Microwave Ablation System itself is a reusable device, but it is supplied with sterile applicators for each use. The system’s design ensures that the applicators maintain sterility and performance when handled according to the manufacturer’s guidelines, which are critical for safe and effective procedural use.
What regulatory pathways has the AveCure BT Microwave Ablation System followed, and what does this mean for its use?
The AveCure BT Microwave Ablation System has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD), classifying it as a Class II (NEY) device. This means it has been evaluated for substantial equivalence to a predicate device and meets EU safety and performance requirements, ensuring its use adheres to established regulatory standards for microwave ablation systems.
Are there different sizes or models of applicators available for the AveCure BT Microwave Ablation System, and how would I know which one to choose?
The system includes multiple applicator models, as indicated by the diverse registration numbers (e.g., 1000523114, 1721676, etc.), which likely correspond to different sizes or configurations. The manufacturer’s documentation or technical support should be consulted to determine the appropriate applicator for specific clinical needs, such as tissue depth or lesion size, ensuring optimal ablation outcomes.
How should the AveCure BT Microwave Ablation System and its applicators be stored to maintain sterility and functionality?
The system and sterile applicators must be stored following the manufacturer’s guidelines to preserve sterility and performance. This typically includes proper packaging, environmental controls (e.g., temperature, humidity), and avoiding contamination. Adhering to these instructions ensures the device remains ready for use when needed, particularly for procedures requiring precise and reliable ablation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medwaves, Healthcare Professionals - Medwaves, Avecure BT Microwave Ablation System - Medwaves | FDA Reference
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192406 | Class II | Active |
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Manufacturer
- Manufacturer
- Medwaves, Inc.
Sources (2)
- FDA 510(k) K192406 24 fields · synced Sep 18, 2026
- EUDAMED c15add9f-a23f-4d54-a3c6-e7d6c4b9f763 61 fields · synced Jul 9, 2026