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U.S. Department of Health and Human Services

Product Classification
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Device high intensity ultrasound system for prostate tissue ablation
Regulation Description High intensity ultrasound system for prostate tissue ablation.
Definition Prostate tissue ablation
Physical State The system consists of a console, a probe with therapy transducer(s), and single use accessories.
Technical Method Uses high intensity ultrasound to heat target tissue within the prostate gland, causing coagulation necrosis of that tissue.
Target Area The prostate gland
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePLP
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.4340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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