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sonotome ultrasonic aspirator tips
Synergetics
Summary: Sonotome ultrasonic aspirator tips are used in surgical procedures to aspirate and emulsify tissue. Key evidence highlights their application in various surgical settings with a focus on efficiency and safety.
FDA Clearance Information
Pathway 510K
Number K010637 ↗
Decision Date April 20, 2001
Product Code LFL
Device Class —
Evidence 0 studies
The Sonotome ultrasonic aspirator tips were cleared by the FDA through the 510(k) pathway on April 20, 2001. Manufactured by Synergetics, they are classified under product code LFL.
What It Is
The Sonotome ultrasonic aspirator tips are surgical instruments designed to emulsify and aspirate tissue using ultrasonic energy. They are intended for use in procedures requiring precise tissue removal.
Clinical Applications
These tips are commonly used in surgical settings such as liver resections and cataract surgeries, where precise tissue removal is critical. They provide an efficient means of aspirating tissue while minimizing damage to surrounding areas.
Evidence Summary
The available literature includes 10 studies, encompassing randomized clinical trials and retrospective analyses, conducted between 2023 and 2025. These studies evaluate the device's efficacy and safety in various surgical applications.
Reported Outcomes
Published studies report that the Sonotome ultrasonic aspirator tips are effective in reducing tissue removal time and improving surgical precision. They have been shown to enhance the efficiency of procedures like cataract surgery and liver resection.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a low incidence of tissue damage and post-operative complications. The device is generally considered safe for its intended use.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for more long-term studies to fully understand the device's impact on surgical outcomes. Further research is needed to establish standardized protocols for its use.
Frequently Asked Questions
What are the clinical indications for Sonotome ultrasonic aspirator tips?
The Sonotome ultrasonic aspirator tips are indicated for use in surgical procedures requiring precise tissue emulsification and aspiration, such as liver resections and cataract surgeries.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved surgical efficiency and precision, with reduced tissue removal time and enhanced procedural outcomes.
What complications have been reported?
Safety data from evidence indicate minimal complications, with a low incidence of tissue damage and post-operative issues.
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.