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km products suction tips
Km Products
Summary: KM Products Suction Tips are medical devices used in surgical procedures to remove fluids and debris. Cleared by the FDA via the 510(k) pathway, they are commonly used in portal vein surgeries. Key evidence includes studies on suction efficiency and clogging prevention.
FDA Clearance Information
Pathway
510K
Number
K850240 ↗
Decision Date
March 6, 1985
Product Code
JOL
Device Class
Class 2
Evidence
0 studies
The KM Products Suction Tips were cleared by the FDA via the 510(k) pathway on March 6, 1985. Manufactured by Km Products, they are classified as Class II devices under product code JOL.
What It Is
KM Products Suction Tips are designed for use in surgical settings to aspirate fluids and debris from the surgical site. They are intended for use in procedures involving the portal vein and other related clinical applications.
Clinical Applications
These suction tips are commonly used in surgeries where efficient removal of fluids is critical, such as in portal vein surgeries. They are also employed in orthopedic and neurosurgical procedures to maintain a clear surgical field.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and case series, published between 2018 and 2022. These studies investigate aspects like suction efficiency and clogging prevention.
Reported Outcomes
Published studies report that the KM Products Suction Tips are effective in maintaining a clear surgical field by efficiently removing fluids and debris. A study highlighted the development of a no-clog suction tip using 3D printing technology, which improved surgical efficiency.
Safety Profile
Reported complications include occasional clogging of the suction tips during use, which can interrupt surgical procedures. However, advancements in design, such as the no-clog feature, have been developed to mitigate these issues.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the KM Products Suction Tips. Further research is needed to assess long-term outcomes and to compare their performance with other suction devices.
Frequently Asked Questions
What are the clinical indications for KM Products Suction Tips?
The clinical indications include use in portal vein surgeries and other procedures requiring fluid and debris removal.
What outcomes have been reported in clinical studies?
Studies report effective fluid removal and improved surgical efficiency, particularly with the no-clog design.
What complications have been reported?
Safety data indicate occasional clogging, though design improvements have been made to address this issue.
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.