đź“‹ FDA Reference
stryker interpulse handpiece set splash shields irrigation and suction tips rechargeable battery pack
Stryker Instruments
Summary: The Stryker Interpulse Handpiece Set is a medical device used for irrigation and suction in surgical procedures. It is typically utilized by surgeons in various specialties to ensure a clean surgical field.
FDA Clearance Information
Pathway
510K
Number
K972069 ↗
Decision Date
July 29, 1997
Product Code
FQH
Device Class
Class 2
Evidence
0 studies
The Stryker Interpulse Handpiece Set was cleared via the FDA 510(k) pathway on July 29, 1997. Manufactured by Stryker Instruments, it is classified as a Class 2 device under product code FQH.
What It Is
The Stryker Interpulse Handpiece Set is a surgical tool designed for irrigation and suction during procedures. It includes splash shields, irrigation and suction tips, and a rechargeable battery pack, allowing for efficient and sterile management of fluids. This device helps maintain a clear operative field by removing debris and fluids, which is critical for the success of many surgical interventions.
Clinical Applications
This device is commonly used in surgical settings, particularly in orthopedic, general, and vascular surgeries. It is essential in procedures where maintaining a clear view of the surgical site is crucial, such as joint replacements or abdominal surgeries. Surgeons and operating room staff rely on it to enhance visibility and reduce the risk of infection by effectively managing fluids.
Indications for Use
The FDA indications suggest that this device is intended for use in surgical procedures requiring irrigation and suction. It is suitable for patients undergoing surgeries where fluid management is necessary to maintain a clear and sterile field.
Practical Considerations
The device is compatible with various surgical settings and is designed for ease of use with its rechargeable battery pack. Surgeons should ensure the correct sizing of tips and shields for specific procedures to optimize performance. Regular maintenance and proper sterilization are essential for effective operation.
Frequently Asked Questions
What is the Stryker Interpulse Handpiece Set used for?
It is used for irrigation and suction during surgical procedures to maintain a clear and sterile field.
What specialties typically use this device?
Specialties such as orthopedics, general surgery, and vascular surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in surgeries requiring irrigation and suction to manage fluids and maintain a clear operative field.
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.