đź“‹ FDA Reference
series 2900 synthetic contact tips gu use
Sharplan Lasers
Summary: The Series 2900 Synthetic Contact Tips are used in conjunction with lasers for precise surgical applications. They are primarily utilized by surgeons in procedures involving the portal vein and related structures.
FDA Clearance Information
Pathway
510K
Number
K871865 ↗
Decision Date
September 8, 1987
Product Code
LNK
Device Class
Class 2
Evidence
0 studies
The Series 2900 Synthetic Contact Tips were cleared through the FDA 510(k) pathway on September 8, 1987. Manufactured by Sharplan Lasers, this device is classified as Class 2 under product code LNK.
What It Is
The Series 2900 Synthetic Contact Tips are specialized attachments designed for use with surgical lasers. These tips facilitate precise contact with tissue, allowing for controlled laser application. They are particularly useful in procedures requiring high precision, such as those involving delicate vascular structures.
Clinical Applications
These contact tips are commonly used in surgical settings, particularly in procedures involving the portal vein. They are favored in specialties such as vascular surgery and interventional radiology, where precision is critical. The device is suitable for adult patients undergoing procedures that require meticulous laser application.
Indications for Use
The FDA indications suggest that this device is intended for use in surgeries involving the portal vein and associated structures. It is suitable for patients requiring precise laser intervention in these areas.
Practical Considerations
The Series 2900 tips are available in various sizes to accommodate different surgical needs. They are compatible with a range of surgical lasers, and clinicians should ensure proper attachment and calibration before use. Technique considerations include maintaining a steady hand for optimal precision.
Frequently Asked Questions
What is Series 2900 Synthetic Contact Tips used for?
They are used for precise laser application in surgical procedures, particularly involving the portal vein.
What specialties typically use this device?
Vascular surgery and interventional radiology are the primary specialties using this device.
What are the FDA-cleared indications?
The device is indicated for use in surgeries involving the portal vein and related structures, requiring precise laser application.
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.