đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For aspiration and removal of fluids, blood, and debris during surgical procedures.
- For use with compatible surgical suction or aspiration equipment to help maintain a clear operative field.
Clinical Applications
- Removing blood and other fluids during open surgical procedures.
- Removing tissue debris and irrigation fluid from the operative field.
- Maintaining visibility during procedures that require continuous or intermittent surgical suction.
- Using a surgical suction system with a tip selected for the procedure and operative site.
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.
Practical Considerations
- Tip shape, diameter, length, and flexibility should match the procedure, access route, and required suction level.
- Confirm compatibility with the suction tubing, canister, connector, and aspiration source before use.
- Follow the specific product labeling for sterile handling, cleaning, reuse, and disposal; many surgical tips are single-use.
- Use controlled suction near delicate tissue to reduce the risk of tissue injury or unintended aspiration.
- MRI safety depends on the materials and configuration of the specific tip and connected equipment; do not assume MRI compatibility without manufacturer labeling.
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.