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pharma-plast suction tip type orthopae-
Zimmar Consulting
Summary: The Pharma-Plast Suction Tip Type Orthopae is a medical device used in surgical procedures for effective suctioning of fluids. It is primarily used by surgeons in operating rooms, particularly in procedures involving prostate artery embolization.
FDA Clearance Information
Pathway
510K
Number
K843469 ↗
Decision Date
November 19, 1984
Product Code
JOL
Device Class
Class 2
Evidence
0 studies
The Pharma-Plast Suction Tip Type Orthopae was cleared through the FDA 510(k) pathway on November 19, 1984. Manufactured by Zimmar Consulting, it is classified as a Class II device under product code JOL.
What It Is
The Pharma-Plast Suction Tip Type Orthopae is a specialized suction device designed for use in surgical settings to remove fluids and debris from the surgical field. It is constructed to provide precise control and efficient fluid removal, which is crucial during delicate procedures. The device's design allows for easy handling and maneuverability, making it a valuable tool in maintaining a clear operative field.
Clinical Applications
This suction tip is commonly used in urological surgeries, particularly in prostate artery embolization procedures. It is suitable for use in hospital operating rooms and outpatient surgical centers. The device is beneficial in procedures where maintaining a clear view of the surgical site is critical, such as in minimally invasive surgeries and complex urological interventions.
Indications for Use
The device is indicated for use in surgical procedures that require the removal of fluids and debris from the operative field. It is particularly useful in surgeries involving the prostate, where precise fluid management is essential.
Practical Considerations
The Pharma-Plast Suction Tip Type Orthopae is typically available in various sizes to accommodate different surgical needs. It is compatible with standard suction systems used in operating rooms. Clinicians should ensure proper connection and secure handling to maximize its effectiveness during procedures.
Frequently Asked Questions
What is the Pharma-Plast Suction Tip Type Orthopae used for?
It is used for suctioning fluids and debris during surgical procedures, particularly in prostate artery embolization.
What specialties typically use this device?
Urology and surgical specialties that perform procedures requiring precise fluid management, such as prostate surgeries.
What are the FDA-cleared indications?
The device is indicated for use in surgical procedures requiring fluid and debris removal, especially in prostate-related surgeries.
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.