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U.S. Department of Health and Human Services

Product Classification
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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 CodePZP
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
Third Party Review Not Third Party Eligible
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