XPS 3000 System with Reciprocating Adapter and Suction Cannulae
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K010666 FDA 510(k)
- FDA Product Code
- QPB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5040 FDA 510(k)
- Regulation Number
- 878.5040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The XPS 3000 System with Reciprocating Adapter and Suction Cannulae is a System, Suction, Lipoplasty for Removal device, designed for the aspiration of soft tissue and fluid during surgical procedures. It combines powered instrumentation with suction capabilities to facilitate lipoplasty and other soft tissue contouring applications in plastic surgery settings. The reciprocating adapter enhances precision in tissue removal, while the suction cannulae assist in fluid evacuation, supporting aesthetic and reconstructive interventions.
This device is supplied as a modular system including a power control console, footswitches, connection cables, and handpieces compatible with burs, blades, drills, rasps, and cannulae. It is intended for single-use or reusable components (as specified by the manufacturer) and is classified under Device Class II per FDA regulations. The system requires proper sterilization and storage per manufacturer guidelines, with no specific MRI safety restrictions noted. Authorized under FDA 510(k) clearance (K010666), it adheres to 21 CFR 878.5040 for lipoplasty devices.
Frequently asked questions
What is the XPS 3000 System with Reciprocating Adapter and Suction Cannulae used for?
The XPS 3000 System is designed specifically for lipoplasty and soft tissue contouring procedures in plastic surgery. It combines powered instrumentation with suction capabilities to aspirate soft tissue and fluid during surgical interventions, enhancing precision in aesthetic and reconstructive surgeries. The reciprocating adapter improves control during tissue removal, while the suction cannulae efficiently evacuate fluids, supporting smoother and more effective contouring outcomes.
How is the XPS 3000 System supplied, and what components are included?
The XPS 3000 System is supplied as a modular setup, including a power control console, footswitches, connection cables, and handpieces. These handpieces are compatible with various tools such as burs, blades, drills, rasps, and cannulae, allowing flexibility for different surgical techniques. The system is designed to accommodate both single-use and reusable components, depending on the specific part and manufacturer guidelines.
Are any components of the XPS 3000 System reusable, and if so, how should they be sterilized?
The XPS 3000 System includes components that can be either single-use or reusable, as specified by the manufacturer. Reusable parts must be sterilized according to strict protocols outlined by Medtronic Xomed to ensure safety and efficacy. Proper sterilization methods, such as autoclaving or chemical sterilization, are critical to prevent contamination and maintain device integrity for repeated use. Always follow the manufacturer’s instructions for sterilization and storage.
Does the XPS 3000 System have any MRI safety restrictions?
The XPS 3000 System does not have any specific MRI safety restrictions noted in the available documentation. However, it is essential to verify compatibility with MRI equipment and protocols for each surgical setting, as residual metallic components or power sources could pose risks in certain MRI environments. Always consult the manufacturer’s guidelines and local MRI safety protocols before use.
What regulatory clearance does the XPS 3000 System hold, and how is it classified?
The XPS 3000 System with Reciprocating Adapter and Suction Cannulae holds FDA 510(k) clearance under the reference number K010666. It is classified under Device Class II, which indicates a moderate level of regulatory oversight. This classification aligns with its intended use for lipoplasty and soft tissue contouring procedures, ensuring it meets established safety and performance standards for such applications.
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: PDF XPS Model 3000 System User's Gui, Xps 3000 System With Reciprocating Adapter and Suction Cannulae, Medtronic Xomed XPS 3000 User manual - ManualMachine.com, PDF Medtronic XPS 3000 User's Guide.pdf - iFixit
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010666 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA 510(k) K010666 24 fields · synced Oct 1, 2026