đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Cutting tissue during surgical procedures.
- Coagulating tissue and controlling bleeding during surgical procedures.
- Use with compatible electrosurgical units when electrosurgical cutting or coagulation is required.
Clinical Applications
- Incising or dissecting tissue during open surgical procedures.
- Coagulating small areas of bleeding tissue during surgery.
- Combined cutting and coagulation during procedures requiring electrosurgical tissue manipulation.
Practical Considerations
- The pencil must be connected to a compatible electrosurgical unit and used according to the generator and instrument instructions.
- PTFE-coated and uncoated electrode tips, along with different tip sizes and shaft lengths, may be selected according to the procedure.
- The active electrode can cause unintended burns if it contacts the patient, operating-room staff, surgical drapes, or conductive materials.
- The device is not an MRI device and should not be used in the MRI environment unless the specific product labeling states otherwise.
- Use is contraindicated or inappropriate when the electrosurgical generator, pencil, electrode, insulation, or patient return-electrode system is incompatible, damaged, or improperly positioned.
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.