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rigid suction tips
Kelleher
Summary: Rigid suction tips by Kelleher are used for precise suction in surgical settings. Cleared by FDA in 1982, they are supported by studies exploring their application in tissue manipulation and fluid extraction.
FDA Clearance Information
Pathway
510K
Number
K822255 ↗
Decision Date
August 25, 1982
Product Code
KTR
Device Class
Class 2
Evidence
0 studies
The Kelleher rigid suction tips were cleared through the FDA 510(k) pathway on August 25, 1982. They are classified as Class 2 devices under product code KTR.
What It Is
Rigid suction tips are surgical instruments designed for precise suction and fluid removal during procedures. They are commonly used in surgeries requiring controlled suction, such as endonasal and minimally invasive surgeries.
Clinical Applications
These devices are frequently used in surgical settings where precise suction is necessary, such as in endonasal endoscopic skull base surgeries and minimally invasive procedures. They facilitate tissue manipulation and fluid extraction.
Evidence Summary
The literature includes four studies ranging from 1982 to 2023, covering various applications of suction devices. The studies include explorative design studies and reports on tissue adhesive applications.
Reported Outcomes
Published studies report that rigid suction tips are effective in providing precise suction during surgical procedures, aiding in tissue manipulation and fluid extraction. They have been successfully used in endonasal surgeries and minimally invasive procedures.
Safety Profile
Reported complications include the potential for imprecise application of materials when used as applicators in endonasal surgeries. No significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies specifically addressing rigid suction tips. Further research is needed to explore long-term outcomes and potential complications in diverse surgical settings.
Frequently Asked Questions
What are the clinical indications for rigid suction tips?
Rigid suction tips are indicated for use in surgical procedures requiring precise suction, such as endonasal and minimally invasive surgeries.
What outcomes have been reported in clinical studies?
Studies report effective suction and tissue manipulation, particularly in endonasal and minimally invasive surgeries.
What complications have been reported?
Reported complications include potential imprecision in material application during endonasal surgeries, with no significant adverse events noted.
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.