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Reusable Interface Cable 1 5 M Prd-Ifc-002
Summary: The reusable interface cable 1.5m PRD-IFC-002 by Creo Medical is a Class 2 medical device used in tumor ablation procedures. It is typically utilized by interventional radiologists and oncologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242061 ↗
Decision Date ?
August 15, 2024
Product Code ?
KNS
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on August 15, 2024. It is manufactured by Creo Medical and classified as a Class 2 device under product code KNS.
What It Is
The reusable interface cable 1.5m PRD-IFC-002 is designed to connect ablation devices to their power sources or control units. It ensures reliable transmission of energy required for effective tumor ablation. The cable's design supports repeated use, making it a cost-effective option for medical facilities.
FDA-Cleared Indications
- Used with compatible tumor-ablation equipment during procedures intended to destroy tumor tissue.
- Intended for use when the cable is required to connect the ablation system with its associated power source or control unit.
Clinical Applications
- Connecting compatible ablation equipment during image-guided tumor-ablation procedures.
- Supporting percutaneous, laparoscopic, or surgical tumor-ablation procedures when used with a compatible cleared ablation system.
- Use in hospital, ambulatory, or specialized oncology procedural settings according to the connected system's labeling.
Practical Considerations
- The listed cable length is 1.5 meters.
- Compatibility must be confirmed with the specific Creo Medical ablation generator, applicator, and system configuration before use.
- The cable is reusable and should be inspected, cleaned, disinfected, and reprocessed according to the manufacturer's instructions for use.
- Do not use a cable with damaged insulation, connectors, pins, or strain relief.
- MRI safety is not established by the information provided here; follow the cable and connected system's MRI labeling before use in or near an MRI environment.
Frequently Asked Questions
What is the reusable interface cable 1.5m PRD-IFC-002 used for?
It is used to connect ablation devices to their power sources or control units during tumor ablation procedures.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures that aim to destroy tumor tissues through ablation.
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.