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510(k) Data Aggregation
Device Name
Vanquish Water Vapor Ablation DeviceManufacturer
Date Cleared
2025-11-26
(118 days)
Product Code
Regulation Number
876.4300Type
TraditionalReference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Vanquish Water Vapor Ablation System is indicated for the thermal ablation of targeted prostate tissue via a transurethral approach.
Device Description
The Vanquish Water Vapor Ablation System provides a method of focal thermal ablation that utilizes the high energy stored in water vapor to target prostate tissue. In a minimally invasive transurethral outpatient procedure performed under transrectal ultrasound (TRUS) guidance, sterile water is heated within the system and converted into vapor. This vapor is then delivered through small emitter holes at the distal end of a transurethral needle into the prostate tissue.
AI/ML Overview
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