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U.S. Department of Health and Human Services

Product Classification

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Device water-induced thermotherapy system, benign prostatic hyperplasia
Regulation Description Endoscopic electrosurgical unit and accessories.
Definition Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia
Physical State The device consists primarily of a water heating unit and an applicator. The applicator is a catheter-like device inserted into the urethra. The dilation balloon and the heat conductive area of the applicator are positioned in the prostatic urethra.
Technical Method The prostate is heated by means of hot water passed through an applicator and dilated by a balloon. Radio frequency energy is applied to the prostate using electrodes. Conductive heating and dilation of the prostatic urethra produces relief of symptoms of BPH.
Target Area Prostate
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General & Plastic Surgery
Product CodeOEK
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 876.4300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible