Product Classification

• Device: fluid jet removal system
• Regulation Description: Fluid jet system for prostate tissue removal.
• Definition: The system is used for removal of prostate tissue with a fluid jet.
• Physical State: The system consists of a hand piece through which the fluid exits, and may have a conformal planning unit (CPU), which is used in treatment planning.
• Technical Method: The system is a personalized image-guided tissue removal system that uses a high-velocity fluid jet to resect and remove a predetermined volume of tissue.
• Target Area: Prostate.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: Gastroenterology/Urology
• Product Code: PZP
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: 510(k)
• Regulation Number: 876.4350
• 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

• Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible