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diego powered dissector handpiece with starlink image-guided adapter mounting interface
Gyrus Ent
Summary: The Diego Powered Dissector Handpiece is a surgical tool used for precise tissue ablation, commonly in ENT procedures. It is utilized by surgeons in operating rooms for tumor removal and other delicate dissections.
FDA Clearance Information
Pathway
510K
Number
K030343 ↗
Decision Date
May 2, 2003
Product Code
HAW
Device Class
Class 2
Evidence
0 studies
The Diego Powered Dissector Handpiece was cleared via the FDA 510k pathway on May 2, 2003. Manufactured by Gyrus Ent, it is classified as a Class II device under product code HAW.
What It Is
The Diego Powered Dissector Handpiece is a surgical instrument designed for precise tissue ablation and dissection. It integrates with image-guided systems via the Starlink adapter, enhancing accuracy in surgical procedures. The device is powered, allowing for efficient and controlled cutting, which is crucial in delicate surgeries such as those involving the ear, nose, and throat.
Clinical Applications
This device is primarily used in otolaryngology (ENT) surgeries, particularly for tumor ablation and removal. It is suitable for use in hospital operating rooms or specialized surgical centers. The handpiece is beneficial in procedures requiring precision, such as sinus surgeries, polypectomies, and other head and neck surgeries, often involving adult and pediatric patients.
Indications for Use
The FDA-cleared indications suggest this device is intended for the ablation of soft tissue tumors. It is particularly useful in surgeries where precision and minimal tissue damage are paramount, such as in ENT operations.
Practical Considerations
The Diego Powered Dissector Handpiece is compatible with image-guided systems, which enhances its utility in complex surgeries. Surgeons should ensure compatibility with existing surgical systems and be trained in its use for optimal outcomes. The device's powered nature requires access to appropriate power sources and maintenance protocols.
Frequently Asked Questions
What is the Diego Powered Dissector Handpiece used for?
It is used for precise tissue ablation and dissection, commonly in ENT surgeries.
What specialties typically use this device?
This device is typically used by otolaryngologists (ENT specialists) in surgical settings.
What are the FDA-cleared indications?
It is indicated for the ablation of soft tissue tumors, particularly in ENT procedures.
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.