đź“‹ FDA Reference
sorbastace
Hemostace
Summary: Sorbastace is a hemostatic device used to control bleeding during surgical procedures. It is primarily used by surgeons in various specialties to manage bleeding in operative settings.
FDA Clearance Information
Pathway
510K
Number
K965034 ↗
Decision Date
April 9, 1998
Product Code
QSY
Device Class
—
Evidence
0 studies
Sorbastace was cleared through the FDA 510k pathway on April 9, 1998, by the manufacturer Hemostace. It is classified under product code QSY with no specific class designation.
What It Is
Sorbastace is a hemostatic device designed to aid in the control of bleeding during surgical procedures. It works by providing a physical barrier to bleeding sites, promoting clot formation. This device is particularly useful in situations where traditional methods of hemostasis are inadequate or impractical.
Clinical Applications
Sorbastace is commonly used in surgical settings across various specialties, including general surgery, cardiovascular surgery, and orthopedic surgery. It is particularly beneficial in procedures where bleeding control is critical, such as liver resections or spinal surgeries. The device is suitable for use in both inpatient and outpatient surgical facilities.
Indications for Use
The FDA indications for Sorbastace include its use in controlling bleeding during surgical procedures. It is intended for patients undergoing surgeries where bleeding management is necessary to ensure procedural success and patient safety.
Practical Considerations
Sorbastace is available in various sizes to accommodate different surgical needs and anatomical locations. It is compatible with standard surgical techniques and instruments. Clinicians should ensure proper placement and adherence to the manufacturer's guidelines for optimal results.
Frequently Asked Questions
What is Sorbastace used for?
Sorbastace is used to control bleeding during surgical procedures.
What specialties typically use this device?
Surgical specialties such as general surgery, cardiovascular surgery, and orthopedic surgery commonly use Sorbastace.
What are the FDA-cleared indications?
Sorbastace is indicated for use in controlling bleeding during surgical procedures.
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.