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suction tips
Wells Johnson
Summary: Suction tips by Wells Johnson are used for surgical procedures to maintain a clear field. Key evidence highlights bacterial contamination risks over time.
FDA Clearance Information
Pathway
510K
Number
K832520 ↗
Decision Date
October 20, 1983
Product Code
GEA
Device Class
Class 1
Evidence
0 studies
The suction tips by Wells Johnson were cleared through the FDA 510(k) pathway on October 20, 1983. They are classified as Class 1 medical devices.
What It Is
Suction tips are medical devices used to remove fluids and debris from surgical sites, ensuring a clear view for surgeons. They are essential in various surgical procedures.
Clinical Applications
Commonly used in surgical settings, suction tips help maintain a clear surgical field by removing blood and other fluids. They are vital in procedures with significant bleeding.
Evidence Summary
The literature includes 15 studies, with types ranging from RCTs to case series, published between 2022 and 2024. These studies explore contamination, noise pollution, and device innovation.
Reported Outcomes
Published studies report that suction tips can become contaminated over time, which may affect surgical outcomes. Modifications in tip geometry can reduce noise pollution, enhancing the surgical environment.
Safety Profile
Reported complications include bacterial contamination of suction tips over extended use, which could pose infection risks. Noise pollution from suction devices is also noted as a potential stressor.
Evidence Limitations
Current evidence lacks large-scale RCTs specifically evaluating long-term safety and efficacy. Further research is needed to explore innovative designs and their impact on clinical outcomes.
Frequently Asked Questions
What are the clinical indications for suction tips?
Suction tips are indicated for use in surgical procedures to clear fluids and debris, ensuring a clear surgical field.
What outcomes have been reported in clinical studies?
Studies report time-dependent bacterial contamination and noise pollution as key outcomes affecting surgical procedures.
What complications have been reported?
Safety data indicate bacterial contamination and noise pollution as potential complications associated with suction tip use.
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.