📋 FDA Reference
Cordis Webster Ref-Star Ex Surface Reference Device Model S D-1204-01 -02 -03 and -04
Cordis Webster
Summary: The Cordis Webster Ref-Star Ex is a surface reference device used in tumor ablation procedures. It is primarily utilized by interventional radiologists and oncologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K980961 ↗
Decision Date ?
May 28, 1998
Product Code ?
DRF
Device Class ?
Class 2
Evidence ?
0 studies
The Cordis Webster Ref-Star Ex was cleared via the FDA 510k pathway on May 28, 1998. It is manufactured by Cordis Webster and classified as a Class 2 medical device.
What It Is
The Cordis Webster Ref-Star Ex is a surface reference device designed for use in tumor ablation procedures. It assists in the accurate placement and monitoring of ablation devices, ensuring precise targeting of tumor tissues. This device is crucial for enhancing the efficacy and safety of ablation therapies by providing reliable reference points during the procedure.
FDA-Cleared Indications
- The FDA record identifies this device as a surface reference device under product code DRF.
- The available indication summary does not state a specific anatomical site, procedure, tumor type, or imaging modality.
Clinical Applications
- Use as an external surface reference during procedures requiring image-based localization.
- Use to help establish or maintain a reference point for procedural imaging and device positioning, according to the cleared labeling.
Practical Considerations
- Models S, D-1204-01, D-1204-02, D-1204-03, and D-1204-04 may differ in configuration or size; confirm the exact model and current labeling before use.
- The available record does not establish compatibility with a particular ablation system, CT scanner, MRI system, or navigation platform.
- MRI safety should not be assumed. Review the device-specific labeling and MR conditions before bringing it into the MRI environment.
- Use requires appropriate skin preparation, secure positioning, and imaging-system calibration according to the manufacturer's instructions.
- Contraindications, limitations, sterilization status, and reuse instructions should be taken from the device labeling because they are not provided in the available FDA summary.
Related Literature
The linked study investigated the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes undergoing PCI. It found that short-term DAPT may be effective, but the study's focus on coronary interventions limits its direct applicability to tumor ablation contexts. The findings highlight the importance of tailored therapy durations based on individual patient risk profiles.
Frequently Asked Questions
What is the Cordis Webster Ref-Star Ex used for?
It is used as a surface reference device in tumor ablation procedures to ensure accurate targeting and monitoring.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in hospital settings for tumor ablation.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise tumor ablation, providing reference points for accurate device placement.
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.