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spembly 140 cryosystem probes tips
Keller Instruments
Summary: The Spembly 140 Cryosystem Probes Tips are used in cryosurgery, primarily by interventional radiologists and surgeons, for portal vein-related procedures. They are essential for precise tissue ablation.
FDA Clearance Information
Pathway
510K
Number
K823835 ↗
Decision Date
January 17, 1983
Product Code
HQA
Device Class
Class 2
Evidence
0 studies
The Spembly 140 Cryosystem Probes Tips were cleared through the FDA 510(k) pathway on January 17, 1983. Manufactured by Keller Instruments, this Class 2 device is categorized under product code HQA.
What It Is
The Spembly 140 Cryosystem Probes Tips are specialized tips used in cryosurgical procedures. They function by delivering extreme cold to targeted tissues, causing cellular destruction through freezing. This device is particularly useful in procedures requiring precise ablation of tissues, such as in the treatment of certain vascular conditions.
Clinical Applications
Commonly used in interventional radiology and surgical settings, these probes are essential for procedures involving the portal vein. They are particularly useful in treating conditions like portal vein thrombosis or other vascular abnormalities. The device is suitable for adult patients requiring minimally invasive interventions.
Indications for Use
The FDA indications suggest that this device is used for procedures involving the portal vein, likely in cases where tissue ablation is necessary. This includes conditions such as thrombosis or other vascular abnormalities requiring precise intervention.
Practical Considerations
The Spembly 140 Cryosystem Probes Tips come in various sizes to accommodate different procedural needs. They are compatible with standard cryosurgical systems and require careful handling to maintain their efficacy. Proper technique is crucial to ensure effective tissue ablation.
Frequently Asked Questions
What is Spembly 140 Cryosystem Probes Tips used for?
It is used for cryosurgical procedures involving the portal vein, such as tissue ablation in cases of thrombosis.
What specialties typically use this device?
Interventional radiologists and surgeons commonly use this device in vascular and surgical procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein, particularly where precise tissue ablation is required.
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.