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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 Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(k)
Regulation Number 876.4300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and Food and Drug Administration Staff - Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
Third Party Review Not Third Party Eligible
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