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resurface proshesis
Aesculap Instruments
Summary: The Resurface Prosthesis by Aesculap Instruments is a medical device used for tumor ablation. It is primarily utilized by oncologists and surgical specialists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K781343 ↗
Decision Date
September 27, 1978
Product Code
—
Device Class
—
Evidence
0 studies
The Resurface Prosthesis was cleared through the FDA 510k pathway on September 27, 1978. Manufactured by Aesculap Instruments, this device does not have a specific product code or class designation.
What It Is
The Resurface Prosthesis is a medical device designed for the ablation of tumors. It functions by delivering energy to targeted tissues, causing cellular destruction. This device is typically used in minimally invasive procedures, providing an option for patients who may not be candidates for traditional surgery.
Clinical Applications
This device is commonly used in oncology for the treatment of tumors that are accessible via minimally invasive techniques. It is often employed in settings such as hospitals and specialized cancer treatment centers. The device is suitable for adult patients with specific types of tumors, particularly when surgical resection is not feasible.
Indications for Use
The FDA indications suggest that the Resurface Prosthesis is intended for the ablation of tumors. It is suitable for patients with certain types of tumors where traditional surgical options are limited or not possible.
Practical Considerations
Clinicians should consider the size and location of the tumor when selecting this device. Compatibility with existing surgical instruments and imaging systems should be verified. Proper training in the technique is essential for optimal outcomes.
Frequently Asked Questions
What is Resurface Prosthesis used for?
The Resurface Prosthesis is used for the ablation of tumors, particularly in cases where minimally invasive procedures are preferred.
What specialties typically use this device?
Oncologists and surgical specialists, particularly those involved in minimally invasive procedures, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the ablation of tumors, providing an option for patients with specific tumor types where traditional surgery is not feasible.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.