đź“‹ FDA Reference
sapphire plus scaler mod 300114 plugger mod 300115 cutting mod 300116 spreader mod 300117 tips
San Diego Swiss Machining
Summary: The Sapphire Plus Scaler and its accessories are medical devices used primarily in surgical settings for procedures involving the portal vein. They are typically used by surgeons specializing in hepatobiliary or vascular surgery.
FDA Clearance Information
Pathway
510K
Number
K960889 ↗
Decision Date
May 10, 1996
Product Code
ELC
Device Class
Class 2
Evidence
0 studies
The Sapphire Plus Scaler and its associated tips were cleared through the FDA 510(k) pathway on May 10, 1996. Manufactured by San Diego Swiss Machining, these devices are classified as Class II under product code ELC.
What It Is
The Sapphire Plus Scaler and its modular tips, including the plugger, cutting, and spreader mods, are surgical instruments designed for precision work around the portal vein. These devices are engineered to provide enhanced control and accuracy during procedures, reducing the risk of damage to surrounding tissues. They are typically used in conjunction with other surgical tools to facilitate complex vascular surgeries.
Clinical Applications
These devices are commonly used in hepatobiliary and vascular surgeries, particularly those involving the portal vein. Surgeons may employ these tools in settings such as operating rooms within hospitals or specialized surgical centers. The devices are suitable for adult patients undergoing procedures like portal vein reconstruction or thrombectomy.
Indications for Use
The FDA indications suggest that these devices are intended for use in surgical procedures involving the portal vein. They are particularly useful in cases requiring precise manipulation and cutting of vascular tissues.
Practical Considerations
The Sapphire Plus Scaler and its tips are designed to be compatible with standard surgical handpieces. Surgeons should ensure proper sterilization and handling to maintain device integrity. Familiarity with the device's modular components can enhance surgical efficiency and outcomes.
Frequently Asked Questions
What is the Sapphire Plus Scaler used for?
It is used in surgical procedures involving the portal vein, providing precision in cutting and manipulation of vascular tissues.
What specialties typically use this device?
Surgeons specializing in hepatobiliary and vascular surgery typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in surgical procedures involving the portal vein, particularly where precision is required.
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.