đź“‹ FDA Reference
Renew Disposable Scissor TIPS
Microline Surgical
Summary: Renew Disposable Scissor Tips are surgical instruments used primarily in minimally invasive procedures to cut tissue. They are used by surgeons in various specialties, including general surgery and vascular surgery.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K213127 ↗
Decision Date ?
March 2, 2022
Product Code ?
GEI
Device Class ?
Class 2
Evidence ?
0 studies
The Renew Disposable Scissor Tips by Microline Surgical were cleared via the FDA 510k pathway on March 2, 2022. This device is classified as a Class 2 medical device under product code GEI.
What It Is
The Renew Disposable Scissor Tips are specialized surgical instruments designed for precision cutting during minimally invasive procedures. These disposable tips attach to reusable handles, ensuring both cost-effectiveness and sterility. They are engineered to provide sharp, precise cuts, reducing tissue trauma and improving surgical outcomes.
FDA-Cleared Indications
- For cutting soft tissue during surgical procedures.
- For use with compatible reusable surgical instrument handles.
- Intended for minimally invasive surgical applications requiring tissue cutting.
Clinical Applications
- Cutting soft tissue during laparoscopic surgery.
- Cutting soft tissue during endoscopic surgery.
- Tissue dissection in minimally invasive general surgery.
- Soft-tissue cutting when a sterile, disposable scissor tip is required.
Practical Considerations
- The tips are disposable and should not be reused, resterilized, or used after the labeled expiration date.
- Use only with the compatible Microline Surgical reusable handle and confirm that the tip is securely attached before use.
- Select the appropriate tip size and configuration for the surgical approach and tissue being treated.
- The available FDA information does not establish MRI safety; the device should not be taken into an MRI environment unless the specific product labeling confirms its status.
- Follow the product instructions for inspection, attachment, operation, disposal, and management of damaged or malfunctioning tips.
Frequently Asked Questions
What is Renew Disposable Scissor Tips used for?
They are used for cutting tissue in minimally invasive surgical procedures.
What specialties typically use this device?
Specialties such as general surgery, gynecology, and vascular surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in surgical procedures requiring cutting of soft tissues, especially in minimally invasive surgeries.
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.