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visitec needle range orthopaedic
Visitec
Summary: The Visitec Needle Range Orthopaedic is a medical device used primarily in prostate artery embolization procedures. It is typically utilized by interventional radiologists and urologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K811961 ↗
Decision Date
July 20, 1981
Product Code
—
Device Class
—
Evidence
0 studies
The Visitec Needle Range Orthopaedic was cleared through the FDA 510k pathway on July 20, 1981. It is manufactured by Visitec and does not have a specific product code or class assigned.
What It Is
The Visitec Needle Range Orthopaedic is a specialized needle designed for use in orthopedic procedures, particularly in prostate artery embolization. It facilitates the precise delivery of embolic agents to target areas within the prostate. The device is engineered to ensure accuracy and safety during minimally invasive procedures.
Clinical Applications
This device is commonly used in prostate artery embolization, a procedure aimed at reducing blood flow to the prostate to alleviate symptoms of benign prostatic hyperplasia. It is typically employed by interventional radiologists in a hospital or surgical center setting. The patient population primarily includes older males experiencing urinary symptoms due to prostate enlargement.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving the prostate arteries, particularly for embolization purposes. It is suitable for patients with conditions like benign prostatic hyperplasia that require reduction of blood flow to the prostate.
Practical Considerations
Clinicians should consider the typical needle sizes available and ensure compatibility with embolic agents used in prostate artery embolization. Proper technique is crucial to avoid complications, and practitioners should be trained in interventional radiology procedures.
Frequently Asked Questions
What is Visitec Needle Range Orthopaedic used for?
It is used for prostate artery embolization to treat benign prostatic hyperplasia.
What specialties typically use this device?
Interventional radiologists and urologists primarily use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the prostate arteries, particularly for embolization in cases of benign prostatic hyperplasia.
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.