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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 ?
510(k)
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.
FDA-Cleared Indications
- For use with a compatible ultrasonic surgical aspirator to emulsify or fragment tissue.
- For aspiration and removal of emulsified tissue during surgery.
- For use in surgical procedures requiring ultrasonic tissue disruption and aspiration.
Clinical Applications
- Ultrasonic fragmentation and aspiration of tissue during surgery.
- Controlled removal of tissue when simultaneous emulsification and suction are needed.
- Use as a replaceable or interchangeable tip with a compatible ultrasonic aspirator system.
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.
Practical Considerations
- Tips must be used with the compatible Sonotome ultrasonic aspirator system and associated handpiece, tubing, and suction equipment.
- Tip size and configuration should be selected for the operative site, target tissue, and required degree of precision.
- The device is intended for trained surgical personnel; tissue contact, activation time, irrigation, and suction require careful control to limit unintended injury.
- MRI safety depends on the specific tip, handpiece, and system configuration. Do not assume MRI compatibility; review current manufacturer labeling before use in or near an MRI environment.
- The tip is a surgical instrument or accessory, not a permanent implant. Follow manufacturer instructions for cleaning, sterilization, reuse, or disposal.
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.