📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Use during surgical procedures to aid in the control of bleeding.
- Use when conventional methods of hemostasis are ineffective or impractical.
Clinical Applications
- Adjunctive control of bleeding at operative sites during general surgery.
- Adjunctive control of bleeding during cardiovascular surgical procedures.
- Adjunctive control of bleeding during orthopedic surgical procedures.
- Use at bleeding sites where conventional surgical hemostasis is difficult or inadequate.
Practical Considerations
- Use the available size and shape appropriate for the bleeding site and surgical anatomy.
- Place and handle the device according to the current manufacturer instructions for use.
- Sorbastace is an adjunct to, not necessarily a replacement for, standard surgical hemostatic techniques.
- The supplied FDA record does not establish MRI safety; review the current labeling before MRI exposure.
- Avoid use when the product labeling identifies a contraindication, including situations in which the material is not appropriate for the operative site.
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.