đź“‹ FDA Reference
karl storz scb conmed esu interface module model 20091522
Karl Storz Endoscopy-America
Summary: The Karl Storz SCB Conmed ESU Interface Module is a medical device used for electrosurgical procedures, primarily in tumor ablation. It is typically utilized by surgeons in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K080410 ↗
Decision Date
April 9, 2008
Product Code
ODA
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 9, 2008. Manufactured by Karl Storz Endoscopy-America, it is classified as a Class 2 device under product code ODA.
What It Is
The Karl Storz SCB Conmed ESU Interface Module is an electrosurgical unit interface designed to integrate with surgical systems for precise energy delivery during procedures. It facilitates the connection between electrosurgical generators and surgical instruments, ensuring controlled ablation of tissue. This device is particularly useful in procedures requiring precise tissue removal or coagulation.
Clinical Applications
This device is commonly used in surgical oncology for tumor ablation, where precise energy application is critical. It is utilized in operating rooms across various specialties, including general surgery, gynecology, and urology. The device supports procedures that require meticulous control over tissue ablation, making it suitable for both inpatient and outpatient surgical settings.
Indications for Use
The device is indicated for use in surgical procedures requiring tissue ablation, particularly in the removal or reduction of tumors. It is suitable for patients undergoing surgeries where precise tissue management is necessary.
Practical Considerations
The module is compatible with a range of electrosurgical generators and instruments, allowing for flexibility in surgical setups. Clinicians should ensure compatibility with existing equipment and be trained in the specific techniques for using electrosurgical units effectively.
Frequently Asked Questions
What is the Karl Storz SCB Conmed ESU Interface Module used for?
It is used for integrating electrosurgical generators with surgical instruments to perform precise tissue ablation, especially in tumor removal.
What specialties typically use this device?
Specialties such as general surgery, gynecology, and urology commonly use this device in operating rooms.
What are the FDA-cleared indications?
The device is indicated for surgical procedures requiring tissue ablation, particularly in tumor reduction or removal.
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.