đź“‹ FDA Reference

7mm extended length endoscope dissection tips models vh-1111 vh-1114

Guidant

Summary: The 7mm extended length endoscope dissection tips are specialized surgical instruments used primarily in minimally invasive procedures involving the portal vein. Surgeons, particularly those in vascular and gastrointestinal specialties, utilize these devices.

FDA Clearance Information

Pathway 510K
Decision Date January 10, 2002
Product Code GCJ
Device Class Class 2
Evidence 0 studies

The 7mm extended length endoscope dissection tips, manufactured by Guidant, were cleared via the FDA 510k pathway on January 10, 2002. This Class 2 device is categorized under product code GCJ.

What It Is

This device consists of endoscope dissection tips designed for extended reach and precision in minimally invasive surgeries. The 7mm length allows for enhanced maneuverability and access in complex anatomical regions, particularly around the portal vein. Its design supports precise dissection and tissue manipulation, reducing the need for open surgical approaches.

Clinical Applications

These dissection tips are commonly used in procedures involving the portal vein, such as portal hypertension surgeries or liver resections. Surgeons in specialties like hepatobiliary surgery, gastroenterology, and vascular surgery frequently employ this device in both hospital and outpatient surgical settings. The device is particularly beneficial in patient populations requiring delicate vascular interventions.

Indications for Use

The FDA-cleared indications suggest that this device is intended for use in procedures involving the portal vein, where precise dissection and manipulation are required. It is suitable for patients undergoing minimally invasive surgeries that target vascular structures in the abdominal region.

Practical Considerations

The 7mm extended length is suitable for deep anatomical access, making it compatible with standard endoscopic equipment. Surgeons should be familiar with endoscopic techniques and consider the device's compatibility with existing surgical systems. Proper training in minimally invasive procedures is recommended for optimal use.

Frequently Asked Questions

What is the 7mm extended length endoscope dissection tip used for?

It is used for minimally invasive procedures involving the portal vein, allowing for precise dissection and tissue manipulation.

What specialties typically use this device?

Specialties such as hepatobiliary surgery, gastroenterology, and vascular surgery commonly use this device.

What are the FDA-cleared indications?

The device is indicated for use in procedures involving the portal vein, particularly where precise dissection is necessary.

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.

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