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scb steris or-light interface box
Karl Storz Endoscopy-America
Summary: The SCB Steris OR-Light Interface Box by Karl Storz is a medical device used to integrate surgical lighting systems with other OR technologies. It is primarily used by surgical teams in operating rooms to enhance procedural efficiency.
FDA Clearance Information
Pathway
510K
Number
K051505 ↗
Decision Date
August 11, 2005
Product Code
FTA
Device Class
Class 2
Evidence
0 studies
The SCB Steris OR-Light Interface Box received FDA clearance via the 510(k) pathway on August 11, 2005. Manufactured by Karl Storz Endoscopy-America, it is classified as a Class II device under product code FTA.
What It Is
The SCB Steris OR-Light Interface Box is a device designed to facilitate the integration of surgical lighting systems with other operating room technologies. It acts as an interface, allowing for seamless communication and control between different devices. This integration helps optimize the surgical environment by ensuring that lighting and other equipment can be managed efficiently from a central point.
Clinical Applications
This device is commonly used in surgical settings, particularly in operating rooms where complex procedures are performed. It is beneficial in specialties such as general surgery, orthopedics, and neurosurgery, where precise lighting and equipment coordination are crucial. The device supports surgical teams by providing an integrated system that enhances workflow and reduces the need for manual adjustments during procedures.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in surgical environments where integration of lighting systems with other OR technologies is necessary. It is suitable for patients undergoing surgical procedures that require precise lighting and equipment coordination.
Practical Considerations
The SCB Steris OR-Light Interface Box is typically compatible with a range of surgical lighting systems and may require specific configurations depending on the operating room setup. Clinicians should ensure compatibility with existing OR equipment and consider training for optimal use.
Frequently Asked Questions
What is SCB Steris OR-Light Interface Box used for?
It is used to integrate surgical lighting systems with other operating room technologies to enhance procedural efficiency.
What specialties typically use this device?
Specialties such as general surgery, orthopedics, and neurosurgery commonly use this device in operating rooms.
What are the FDA-cleared indications?
The device is indicated for use in surgical environments requiring integration of lighting systems with other OR technologies.
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.