Product Classification

• 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 Code: QNA
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: 510(k)
• Regulation Number: 876.4690
• 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