Emprint Ablation System
FDA 510(k)Class II (US FDA 510(k))
by Covidien llc
Identifiers
- 510(k) Number
- K163105 FDA 510(k)
- FDA Product Code
- NEY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Emprint Ablation System is a microwave ablation device designed for the treatment of non-resectable liver tumors. It employs microwave energy to create controlled ablation zones, enabling minimally invasive procedures to target and destroy pathological tissue while preserving adjacent healthy liver parenchyma. The system includes a generator and associated accessories for precise application of thermal energy, facilitating targeted tumor eradication with predictable margins.
The device is supplied as a reusable system with sterile disposable accessories, intended for use in clinical settings such as operating rooms or interventional radiology suites. It is classified under FDA regulation 878.4400 and holds a Special 510(k) clearance (K163105) for substantial equivalence in the category of microwave ablation systems and accessories. Compliance with MRI safety standards is implied by its intended use in non-MRI environments, though specific MRI compatibility is not stated. Storage and handling follow standard aseptic protocols for surgical instruments and disposable components.
Frequently asked questions
What is the Emprint Ablation System used for?
The Emprint Ablation System is designed specifically for the treatment of non-resectable liver tumors. It employs microwave energy to create controlled ablation zones, allowing clinicians to target and destroy pathological tissue while minimizing damage to surrounding healthy liver parenchyma. This approach supports minimally invasive procedures, reducing the need for open surgery and enabling targeted tumor eradication with predictable margins.
How is the Emprint Ablation System supplied, and what are the sterility considerations?
The Emprint Ablation System is supplied as a reusable generator system paired with sterile disposable accessories. The disposable components are pre-sterilized, ensuring aseptic conditions for clinical use. Standard aseptic protocols must be followed for handling and storage of both reusable and disposable parts to maintain sterility and prevent contamination.
Is the Emprint Ablation System intended for single-use or reuse?
The Emprint Ablation System itself is a reusable device, consisting of a generator and associated accessories. However, the system includes sterile disposable accessories designed for single-use per procedure. This design ensures patient safety by preventing cross-contamination between cases while maintaining the functionality of the reusable generator.
What regulatory clearance does the Emprint Ablation System hold?
The Emprint Ablation System holds a Special 510(k) clearance (K163105) from the FDA, demonstrating substantial equivalence to existing microwave ablation systems and accessories. This clearance is based on the device’s intended use for treating non-resectable liver tumors and its compliance with FDA regulation 878.4400. The system is classified under the General, Plastic Surgery advisory committee.
Where should the Emprint Ablation System be stored, and what are the handling requirements?
The Emprint Ablation System and its disposable accessories should be stored in accordance with standard aseptic protocols for surgical instruments and disposable medical devices. The reusable generator and reusable accessories must be cleaned, disinfected, and stored in a manner that prevents contamination. Disposable accessories should remain in their sterile packaging until immediately before use, and both reusable and disposable components should be handled with care to avoid damage or compromise of sterility.
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: Emprint™ Ablation System with Thermosphere™ Technology, Emprint™ HP ablation generator with Thermosphere™ technology, Emprint by Covidien LP - lavascular.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163105 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien llc
- FDA Applicant
- Covidien, LLC
Sources (1)
- FDA 510(k) K163105 24 fields · synced Oct 1, 2026