📋 FDA Reference
Rigid Suction TIPS Related Items
Kelleher
Summary: Rigid suction tips by Kelleher are medical devices used for suctioning fluids during surgical procedures. They are primarily used by surgeons and operating room staff.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K822010 ↗
Decision Date ?
August 12, 1982
Product Code ?
JZF
Device Class ?
Class 1
Evidence ?
0 studies
The rigid suction tips by Kelleher were cleared through the FDA 510(k) pathway on August 12, 1982. They are classified as Class 1 devices under product code JZF.
What It Is
Rigid suction tips are medical instruments designed to remove fluids, such as blood or other secretions, from surgical sites. They are typically made of durable materials to withstand sterilization processes and are designed to fit standard suction tubing. These devices are essential in maintaining a clear surgical field, which is crucial for visibility and safety during procedures.
FDA-Cleared Indications
- Evacuation of fluids from a surgical site during operative procedures.
- Use with a compatible surgical suction system to help maintain a clear operative field.
Clinical Applications
- Removing blood and other fluids during general surgical procedures.
- Evacuating fluid during orthopedic and trauma operations.
- Supporting fluid management during vascular surgery when needed to maintain visualization.
Practical Considerations
- Tips are available in different sizes and configurations; the appropriate choice depends on the operative field, anatomy, and required suction flow.
- Confirm that the tip securely connects to compatible suction tubing and that the suction system is functioning before use.
- Follow the specific product labeling for cleaning, sterilization, reuse, and inspection if the device is reusable.
- Avoid obstructing tissue or allowing the tip to adhere to delicate structures; use suction under direct visualization when possible.
- MRI safety depends on the materials and exact model. Verify the manufacturer's labeling before bringing the device into an MRI environment.
Frequently Asked Questions
What is rigid suction tips used for?
Rigid suction tips are used to remove fluids from surgical sites to maintain a clear field during operations.
What specialties typically use this device?
Specialties that commonly use rigid suction tips include general surgery, orthopedic surgery, and trauma surgery.
What are the FDA-cleared indications?
The FDA-cleared indications are for use in surgical procedures to evacuate fluids, ensuring a clear operative field.
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.