đź“‹ FDA Reference

re-new forceps laparoscopic surgical tips

Microline Pentax

Summary: The re-new forceps laparoscopic surgical tips by Microline Pentax are specialized instruments used in minimally invasive surgeries. They are primarily utilized by surgeons in laparoscopic procedures to manipulate tissues and structures within the abdomen.

FDA Clearance Information

Pathway 510K
Decision Date January 22, 1998
Product Code GEI
Device Class Class 2
Evidence 0 studies

The re-new forceps laparoscopic surgical tips were cleared through the FDA 510(k) pathway on January 22, 1998. Manufactured by Microline Pentax, this device is classified as Class 2 under product code GEI.

What It Is

The re-new forceps laparoscopic surgical tips are precision instruments designed for use in laparoscopic surgeries. These tips attach to reusable handles and are used to grasp, manipulate, and dissect tissues during minimally invasive procedures. Their design allows for enhanced control and precision, which is critical in delicate surgical environments.

Clinical Applications

These forceps are commonly used in general surgery, gynecology, and urology for laparoscopic procedures such as cholecystectomies, appendectomies, and hysterectomies. They are particularly useful in settings where minimally invasive techniques are preferred, offering benefits such as reduced recovery time and minimized scarring for patients.

Indications for Use

The FDA indications suggest that these forceps are intended for use in laparoscopic procedures where tissue manipulation is required. They are suitable for patients undergoing surgeries that involve the abdominal cavity.

Practical Considerations

The re-new forceps tips are typically available in various sizes to accommodate different surgical needs and are compatible with standard laparoscopic instruments. Surgeons should ensure proper attachment and secure fitting to avoid intraoperative complications.

Frequently Asked Questions

What is re-new forceps laparoscopic surgical tips used for?

They are used for grasping, manipulating, and dissecting tissues during laparoscopic surgeries.

What specialties typically use this device?

General surgery, gynecology, and urology are the primary specialties that use this device.

What are the FDA-cleared indications?

The device is indicated for use in laparoscopic procedures requiring tissue manipulation within the abdominal cavity.

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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