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electrosurgical pencil with ptfe coated uncoated electrode tips
Xodus Medical
Summary: The electrosurgical pencil by Xodus Medical is a surgical tool used to cut tissue and control bleeding during surgery. It is primarily used by surgeons in various specialties.
FDA Clearance Information
Pathway 510K
Number K081647 ↗
Decision Date August 12, 2008
Product Code GEI
Device Class Class 2
Evidence 0 studies
The electrosurgical pencil by Xodus Medical was cleared through the FDA 510(k) pathway on August 12, 2008. It is classified as a Class 2 medical device.
What It Is
The electrosurgical pencil is a handheld device used in surgical procedures to cut tissue and coagulate bleeding. It operates by delivering high-frequency electrical currents through its electrode tips, which can be either PTFE coated or uncoated. This device is designed to enhance precision and reduce thermal damage to surrounding tissues.
Clinical Applications
Electrosurgical pencils are commonly used in a variety of surgical settings, including general surgery, gynecology, and orthopedics. They are essential in procedures where precise cutting and coagulation are required, such as tumor resections or laparoscopic surgeries. Surgeons use this device to minimize blood loss and improve visibility in the surgical field.
Indications for Use
This device is indicated for use in surgical procedures requiring cutting and coagulation of tissue. It is suitable for patients undergoing surgeries where precise tissue manipulation is necessary.
Practical Considerations
Electrosurgical pencils are available in various lengths and electrode tip sizes to accommodate different surgical needs. They are compatible with standard electrosurgical units and require careful handling to avoid accidental burns. Proper grounding and insulation are crucial for safe operation.
Frequently Asked Questions
What is the electrosurgical pencil used for?
It is used for cutting tissue and controlling bleeding during surgical procedures.
What specialties typically use this device?
Specialties such as general surgery, gynecology, and orthopedics commonly use this device.
What are the FDA-cleared indications?
The device is indicated for surgical procedures requiring tissue cutting and coagulation.
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.