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lapascopic instruments and electrode tips
Modern Medical Equipment Mfg.
Summary: Laparoscopic instruments and electrode tips are used in minimally invasive surgeries to access and treat internal organs. Surgeons, particularly in general and vascular surgery, utilize these tools for precision and reduced recovery time.
FDA Clearance Information
Pathway
510K
Number
K030831 ↗
Decision Date
June 15, 2004
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA's 510(k) pathway on June 15, 2004. It is manufactured by Modern Medical Equipment Mfg. and is classified as a Class 2 device under the product code GEI.
What It Is
Laparoscopic instruments and electrode tips are specialized tools used in minimally invasive surgical procedures. These devices allow surgeons to perform operations through small incisions, using a camera and long-handled instruments. The electrode tips are used for cutting, coagulating, or otherwise manipulating tissues with precision. This approach reduces patient recovery time and minimizes surgical trauma.
Clinical Applications
These instruments are commonly used in general surgery, gynecology, and urology for procedures such as cholecystectomies, appendectomies, and hysterectomies. They are particularly valuable in settings where minimally invasive techniques are preferred, such as outpatient surgical centers and hospitals. The patient population includes those requiring abdominal or pelvic surgeries with a focus on minimizing recovery time and surgical risks.
Indications for Use
The FDA indications suggest these devices are intended for use in laparoscopic procedures, which involve accessing the portal vein and other internal structures. They are suitable for patients requiring minimally invasive surgical interventions.
Practical Considerations
These instruments come in various sizes to accommodate different surgical needs and patient anatomies. Compatibility with standard laparoscopic equipment is essential, and surgeons should be familiar with the specific techniques required for using electrode tips effectively.
Frequently Asked Questions
What is laparoscopic instruments and electrode tips used for?
They are used in minimally invasive surgeries to access and treat internal organs with precision, reducing recovery time and surgical trauma.
What specialties typically use this device?
General surgery, gynecology, and urology are the primary specialties that utilize these devices for minimally invasive procedures.
What are the FDA-cleared indications?
These devices are indicated for use in laparoscopic procedures to access the portal vein and other internal structures, suitable for minimally invasive surgical interventions.
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.