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surgical aspirator tips
Henry Schein
Summary: Surgical aspirator tips by Henry Schein are used in surgical procedures to remove fluids and debris. Cleared by FDA via 510k in 1978. Evidence includes 11 studies, focusing on clinical applications and safety.
FDA Clearance Information
Pathway 510K
Number K781592 ↗
Decision Date December 4, 1978
Product Code DYN
Device Class Class 1
Evidence 0 studies
The surgical aspirator tips by Henry Schein were cleared by the FDA through the 510k pathway on December 4, 1978. They are classified as Class 1 devices under product code DYN.
What It Is
Surgical aspirator tips are medical devices used to remove fluids, blood, and debris during surgical procedures. They are designed for precision and efficiency in maintaining a clear surgical field.
Clinical Applications
These devices are commonly used in various surgical settings, including robotic liver resections and procedures requiring fine needle aspiration cytology. They are essential in maintaining visibility and cleanliness in the operative area.
Evidence Summary
The available literature includes 11 studies, with a mix of RCTs, prospective, and retrospective analyses. The studies span from 2022 to 2025, providing insights into the device's clinical applications and safety.
Reported Outcomes
Published studies report that surgical aspirator tips are effective in maintaining a clear surgical field, particularly in complex procedures like robotic liver resections. They contribute to improved surgical precision and reduced operative time.
Safety Profile
Reported complications include potential for tissue damage if not used correctly, as highlighted in studies focusing on fine needle aspiration cytology. Overall, the device is considered safe when used according to guidelines.
Evidence Limitations
Current evidence is limited by the lack of large-scale randomized controlled trials specifically focused on surgical aspirator tips. Further research is needed to explore long-term outcomes and comparative effectiveness.
Frequently Asked Questions
What are the clinical indications for surgical aspirator tips?
Surgical aspirator tips are indicated for use in procedures requiring fluid and debris removal, such as robotic liver resections and fine needle aspiration cytology.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of a clear surgical field and improved surgical precision, particularly in complex procedures.
What complications have been reported?
Reported complications include potential tissue damage if not used correctly, emphasizing the importance of adherence to usage guidelines.
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.