đź“‹ FDA Reference
reusable abrader tips in 3 5mm 5 5mm configuatio
Chattanooga Group
Summary: The reusable abrader tips by Chattanooga Group are medical devices used for tissue abrasion in surgical procedures. They are primarily utilized by surgeons in various specialties for procedures requiring precise tissue removal.
FDA Clearance Information
Pathway
510K
Number
K853490 ↗
Decision Date
September 6, 1985
Product Code
—
Device Class
—
Evidence
0 studies
The reusable abrader tips were cleared through the FDA 510(k) pathway on September 6, 1985. Manufactured by Chattanooga Group, this device is not classified under a specific product code or class.
What It Is
The reusable abrader tips are surgical instruments designed for the abrasion of tissue. Available in 3.5mm and 5.5mm configurations, they are used to remove or smooth tissue surfaces during surgical procedures. These tips are typically attached to a compatible surgical handpiece, allowing for controlled and precise tissue manipulation.
Clinical Applications
These abrader tips are commonly used in surgical settings, particularly in orthopedic, dermatological, and plastic surgery procedures. They are suitable for use in both hospital operating rooms and outpatient surgical centers. Surgeons utilize these tips for tasks such as debriding wounds, preparing bone surfaces, and smoothing skin grafts.
Indications for Use
The FDA indications suggest that these abrader tips are intended for use in procedures requiring tissue abrasion. This includes patients undergoing surgeries where precise tissue removal is necessary, such as in orthopedic or reconstructive surgeries.
Practical Considerations
The tips are available in two sizes, 3.5mm and 5.5mm, allowing for flexibility depending on the surgical need. Compatibility with specific surgical handpieces should be verified before use. Proper technique is essential to ensure effective and safe tissue abrasion.
Frequently Asked Questions
What is reusable abrader tips used for?
Reusable abrader tips are used for tissue abrasion in surgical procedures, allowing for precise removal or smoothing of tissue surfaces.
What specialties typically use this device?
Specialties such as orthopedics, dermatology, and plastic surgery commonly use these devices during surgical procedures.
What are the FDA-cleared indications?
The device is indicated for use in surgical procedures requiring tissue abrasion, such as debriding wounds or preparing bone surfaces.
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.