Emprint SX Ablation Platform with Thermosphere Technology
FDA 510(k)Class II (US FDA 510(k))
by Covidien llc
Identifiers
- 510(k) Number
- K203303 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 SX Ablation Platform with Thermosphere Technology is a microwave ablation system designed for soft tissue ablation procedures. It combines ablation technology with optional 3D navigation to enhance precision in targeting and placement of ablation antennas during intraoperative and laparoscopic surgeries. The device leverages Thermosphere Technology to deliver controlled microwave energy for tissue ablation, supporting minimally invasive interventions in general and plastic surgery settings.
This platform is supplied as a reusable medical device and is intended for use in surgical environments. It includes a generator and compatible antennas, with optional navigation features for improved accuracy. The system is classified under FDA regulation number 878.4400 and holds a Special 510(k) clearance (K203303) for substantial equivalence. No MRI safety information or sterility details are specified in the provided data.
Frequently asked questions
What is the Emprint SX Ablation Platform with Thermosphere Technology used for?
The Emprint SX Ablation Platform with Thermosphere Technology is designed for soft tissue ablation procedures, delivering controlled microwave energy to target and remove tissue during minimally invasive surgeries. It is particularly suited for general and plastic surgery settings, where precision and reduced invasiveness are critical. The Thermosphere Technology ensures focused energy delivery, enhancing accuracy in ablation while supporting intraoperative and laparoscopic applications.
Is the Emprint SX Ablation Platform reusable or single-use?
The Emprint SX Ablation Platform is supplied as a reusable medical device. This means the generator and compatible antennas are intended for repeated use in surgical environments, provided they are properly cleaned, maintained, and sterilized between procedures. Reusability helps reduce waste and costs while ensuring consistent performance.
Does the Emprint SX Ablation Platform include navigation features?
Yes, the Emprint SX Ablation Platform offers optional 3D navigation capabilities. These features enhance precision by improving the targeting and placement of ablation antennas during surgery. The navigation system helps clinicians achieve greater accuracy, which is particularly valuable in complex or delicate procedures where minimizing tissue damage is important.
What types of antennas are compatible with the Emprint SX Ablation Platform?
The Emprint SX Ablation Platform is designed to work with compatible antennas that deliver microwave energy for ablation. While the exact models or specifications of these antennas are not detailed in the provided data, the system is engineered to support a range of antennas suitable for soft tissue procedures. Compatibility ensures seamless integration between the generator and the ablation tools, optimizing performance and safety.
How is the Emprint SX Ablation Platform regulated in the U.S.?
The Emprint SX Ablation Platform holds a Special 510(k) clearance (K203303) from the FDA, indicating it has been determined to be substantially equivalent to a legally marketed device. It falls under FDA regulation number 878.4400 and is classified as a Class II medical device. This regulatory pathway ensures the device meets safety and effectiveness standards for use in surgical environments, particularly in general and plastic surgery.
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™ SX Ablation Platform With Thermosphere™ Technology - Medigy, Emprint SX Ablation Platform with Thermosphere Technology (K203303 ..., Emprint™ HP ablation generator with Thermosphere™ technology
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203303 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien llc
- FDA Applicant
- Covidien, LLC
Sources (1)
- FDA 510(k) K203303 24 fields · synced Oct 1, 2026