đź“‹ FDA Reference
disposable monopolar laparoscopic tips and reusable handles
Dannik
Summary: The disposable monopolar laparoscopic tips by Dannik are used in minimally invasive surgeries to cut, coagulate, and dissect tissue. Surgeons in specialties like general surgery and gynecology commonly use them.
FDA Clearance Information
Pathway
510K
Number
K211019 ↗
Decision Date
October 28, 2021
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 28, 2021. Manufactured by Dannik, it is classified as a Class 2 medical device under product code GEI.
What It Is
The disposable monopolar laparoscopic tips are surgical instruments used in laparoscopic procedures. They attach to reusable handles and are designed to deliver monopolar electrical energy to cut or coagulate tissue. These tips are essential in minimally invasive surgeries, providing precision and reducing the need for open surgical techniques.
Clinical Applications
These tips are commonly used in laparoscopic procedures across various specialties, including general surgery, gynecology, and urology. They are particularly useful in procedures like cholecystectomies, hysterectomies, and appendectomies. The device is suitable for adult and pediatric patients, depending on the procedure and clinical setting.
Indications for Use
The FDA-cleared indications for this device include its use in laparoscopic surgeries where monopolar energy is needed to cut, coagulate, or dissect tissue. It is intended for patients undergoing minimally invasive procedures.
Practical Considerations
The device is compatible with standard laparoscopic equipment and is available in various sizes to accommodate different surgical needs. Surgeons should ensure proper connection and handle compatibility before use to maximize safety and effectiveness.
Frequently Asked Questions
What is disposable monopolar laparoscopic tips used for?
They are used in laparoscopic surgeries to cut, coagulate, and dissect tissue using monopolar electrical energy.
What specialties typically use this device?
Specialties such as general surgery, gynecology, and urology commonly use this device in minimally invasive procedures.
What are the FDA-cleared indications?
The device is indicated for use in laparoscopic surgeries requiring monopolar energy for cutting, coagulating, or dissecting tissue.
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.