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obturator
Argon Medical
Summary: The obturator by Argon Medical is a device used in embolization procedures. It is FDA 510k cleared and supported by 14 studies, focusing on anatomical guidance and nerve block techniques.
FDA Clearance Information
Pathway
510K
Number
K894157 ↗
Decision Date
September 28, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The obturator by Argon Medical was cleared through the FDA 510k pathway on September 28, 1989. It is classified as a Class 2 device under product code DYB.
What It Is
The obturator is a medical device used primarily in embolization procedures. It facilitates the placement of embolization coils, aiding in the occlusion of blood vessels. Its design is intended for precise navigation and deployment in clinical settings.
Clinical Applications
Commonly used in procedures requiring embolization, the obturator is crucial in interventional radiology for managing vascular abnormalities. It is particularly useful in scenarios where precise coil placement is necessary.
Evidence Summary
The literature includes 14 studies, encompassing various study types such as RCTs and observational studies. These studies span from 2023 to 2024, focusing on anatomical guidance and nerve block techniques.
Reported Outcomes
Published studies report that the obturator is effective in facilitating obturator nerve blocks and embolization procedures. Anatomical studies highlight its role in precise nerve targeting, while clinical studies underscore its efficacy in preventing complications like bladder perforation during transurethral procedures.
Safety Profile
Reported complications include potential iatrogenic nerve injuries, as highlighted in anatomical and clinical studies. However, specific adverse events related to the device itself are not extensively documented in the available literature.
Evidence Limitations
The evidence base is limited by a lack of large-scale RCTs directly evaluating the obturator's efficacy and safety. Further research is needed to explore long-term outcomes and device-specific complications in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for obturator?
The obturator is indicated for use in embolization procedures and obturator nerve blocks, as supported by anatomical and clinical studies.
What outcomes have been reported in clinical studies?
Studies report effective obturator nerve blocks and reduced complications in embolization procedures, particularly in preventing bladder perforation.
What complications have been reported?
Safety data indicate potential iatrogenic nerve injuries, though specific device-related adverse events are not well-documented.
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.