đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Intended for use as an interface for integrating compatible surgical lighting systems with other operating-room equipment.
- Intended for use in operating-room environments where compatible lighting and equipment-control connections are required.
Clinical Applications
- Connecting compatible surgical lights to an operating-room integration system.
- Supporting centralized control or communication between surgical lighting and compatible operating-room equipment.
- Use during surgical procedures performed in an operating room with an appropriately configured integrated equipment system.
Practical Considerations
- Compatibility must be confirmed with the specific surgical lights, control systems, cables, and operating-room integration equipment installed at the facility.
- This is an equipment-interface component rather than a device placed in or on a patient.
- The device should be installed, configured, and serviced by qualified operating-room equipment personnel according to the manufacturer’s instructions.
- MRI compatibility should not be assumed; the device and its connected equipment should be kept out of MRI-controlled areas unless the manufacturer and facility safety program specifically permit their use.
- The record does not provide patient-contact sizing, implant duration, or a defined clinical contraindication list.
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.