đź“‹ FDA Reference

stryker interpulse handpiece set irrigation tips splash shields canal vision tip irrigation suction tips

Stryker Instruments

Summary: The Stryker Interpulse Handpiece Set is a medical device used for irrigation and suction in surgical procedures. It is primarily used by surgeons to maintain a clear surgical field.

FDA Clearance Information

Pathway 510K
Decision Date September 19, 1995
Product Code FQH
Device Class Class 2
Evidence 0 studies

The Stryker Interpulse Handpiece Set was cleared through the FDA 510(k) pathway on September 19, 1995. Manufactured by Stryker Instruments, it is classified as a Class 2 device.

What It Is

The Stryker Interpulse Handpiece Set is a surgical irrigation and suction device designed to assist in maintaining a clear view of the surgical site. It includes various tips and splash shields to facilitate precise irrigation and suction. This device is particularly useful in procedures where visibility and cleanliness of the surgical field are critical.

Clinical Applications

This device is commonly used in orthopedic, general, and vascular surgeries to irrigate and suction fluids from the surgical site. It is particularly beneficial in procedures involving the portal vein or other vascular structures, where maintaining a clear field is essential. Surgeons in hospital operating rooms or outpatient surgical centers frequently use this device.

Indications for Use

The device is indicated for use in surgical procedures requiring irrigation and suction to maintain a clear surgical field. It is suitable for patients undergoing surgeries where fluid management is crucial, such as in vascular or orthopedic procedures.

Practical Considerations

The device comes with various interchangeable tips and splash shields, allowing for customization based on the surgical procedure. It is compatible with standard surgical irrigation systems, and clinicians should ensure proper attachment and secure fit during use.

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 surgical field.

What specialties typically use this device?

Orthopedic, general, and vascular surgeons commonly use this device in their procedures.

What are the FDA-cleared indications?

The device is indicated for use in surgeries requiring irrigation and suction to maintain a clear surgical 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.

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