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U.S. Department of Health and Human Services

Product Classification
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Device ultrasonic urinary stone propulsion device
Definition An ultrasonic urinary stone propulsion device visualizes urinary stones in the upper urinary tract and delivers focused acoustic pulses to reposition the stones to facilitate their passage.
Physical State Ultrasound system and system accessories, external probes.
Technical Method Uses an imaging ultrasound probe to visualize urinary stones in the upper urinary tract and a therapy ultrasound probe to deliver a focused pulse of acoustic energy that repositions the urinary stones.
Target Area Upper urinary tract tissues, kidney.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeQNA
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.4690
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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