đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use in laparoscopic surgical procedures.
- For accessing and manipulating internal tissues and organs during minimally invasive surgery.
- Electrode tips are intended for tissue cutting, coagulation, or related electrosurgical manipulation when used with compatible equipment.
Clinical Applications
- Laparoscopic access and tissue manipulation during abdominal surgery.
- Laparoscopic dissection, cutting, or coagulation when the instrument includes an appropriate electrode tip.
- Use with a laparoscope and compatible laparoscopic surgical equipment in an operating room or ambulatory surgical setting.
Practical Considerations
- Instruments are available in different lengths, diameters, jaw designs, and electrode-tip configurations; selection depends on the procedure and patient anatomy.
- Electrode tips must be compatible with the electrosurgical generator, cables, and laparoscopic instruments used by the surgical team.
- Use requires appropriate laparoscopic visualization, sterile technique, and training in electrosurgical safety.
- The FDA record does not establish MRI safety for every instrument or electrode tip; patients and clinicians should verify the exact model and labeling before an MRI examination.
- Contraindications, precautions, reprocessing requirements, and whether a component is reusable or single-use depend on the specific product labeling.
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.