đź“‹ FDA Reference
Karl Storz Scb Interface Control Model 20090120
Karl Storz Endoscopy-America
Summary: The Karl Storz SCB Interface Control Model 20090120 is a medical device used for controlling ablation devices in tumor treatment. It is primarily used by surgeons and oncologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K070827 ↗
Decision Date ?
May 22, 2007
Product Code ?
ODA
Device Class ?
Class 2
Evidence ?
0 studies
The Karl Storz SCB Interface Control Model 20090120 was cleared through the FDA 510k pathway on May 22, 2007. 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 Interface Control Model 20090120 is a control unit designed to interface with ablation devices used in tumor treatment. It allows precise control and monitoring of the ablation process, ensuring effective and safe treatment. This device integrates with other surgical equipment to facilitate minimally invasive procedures.
FDA-Cleared Indications
- For use as an interface and control unit with compatible Karl Storz surgical equipment and ablation systems.
- For controlling and monitoring compatible equipment used during tumor-ablation procedures, according to the applicable system labeling.
Clinical Applications
- Control of compatible ablation equipment during tumor-treatment procedures.
- Integration with compatible Karl Storz operating-room or minimally invasive surgical equipment.
- Monitoring and adjustment of ablation-system functions by trained clinicians during an indicated procedure.
Practical Considerations
- The control unit must be used with compatible ablation devices, probes, cables, software and accessories identified in the manufacturer’s instructions.
- It is a system-control component, not an ablation probe or an implantable device; the ablation system’s labeling determines the permitted tissue targets, energy settings and clinical indications.
- Operation requires trained personnel familiar with the interface, equipment connections, alarms and emergency shutdown procedures.
- MRI safety depends on the complete connected system and the specific procedure environment; this device should not be taken into an MRI suite unless the manufacturer provides applicable MR safety information.
- Inspect cables, connectors and accessories before use, and follow manufacturer instructions for cleaning, electrical safety, maintenance and servicing.
Frequently Asked Questions
What is Karl Storz SCB Interface Control Model 20090120 used for?
It is used for controlling ablation devices during tumor treatment procedures.
What specialties typically use this device?
Surgical oncologists and interventional radiologists commonly use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in controlling ablation procedures for tumor treatment, providing precise control during minimally invasive surgeries.
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.