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simplicity easy p soft infusion set for infusion and or injection of fluids into the body below the surface of the skin
Sterling Medivations
Summary: The Simplicity Easy P Soft Infusion Set is a medical device used for the infusion or injection of fluids beneath the skin. It is commonly used by healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K021530 ↗
Decision Date
May 21, 2002
Product Code
FPA
Device Class
Class 2
Evidence
0 studies
The Simplicity Easy P Soft Infusion Set was cleared through the FDA 510(k) pathway on May 21, 2002. It is manufactured by Sterling Medivations and is classified as a Class 2 device.
What It Is
The Simplicity Easy P Soft Infusion Set is designed for the subcutaneous delivery of fluids, such as medications or nutrients. It consists of a soft, flexible cannula that is inserted under the skin, connected to tubing that allows for controlled infusion. This device is particularly useful for patients requiring regular or continuous fluid administration.
Clinical Applications
This infusion set is commonly used in settings such as hospitals, outpatient clinics, and home care for patients who need regular fluid administration. It is particularly useful in specialties like oncology, endocrinology, and pain management, where patients may require continuous or intermittent drug delivery. The device is suitable for both adult and pediatric populations.
Indications for Use
The FDA indications for this device include the infusion or injection of fluids beneath the skin. It is suitable for patients who need regular medication delivery, such as insulin for diabetes or chemotherapy for cancer treatment.
Practical Considerations
The Simplicity Easy P Soft Infusion Set typically comes in various sizes to accommodate different patient needs. It is compatible with standard infusion pumps and requires proper aseptic technique during insertion to minimize infection risk.
Frequently Asked Questions
What is the Simplicity Easy P Soft Infusion Set used for?
It is used for the subcutaneous infusion or injection of fluids, such as medications or nutrients.
What specialties typically use this device?
Specialties such as oncology, endocrinology, and pain management commonly use this device.
What are the FDA-cleared indications?
The device is cleared for the infusion or injection of fluids beneath the skin, suitable for patients needing regular medication delivery.
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.