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U.S. Department of Health and Human Services

Product Classification

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Device transurethral electrosurgical unit, benign prostatic hyperplasia
Regulation Description Endoscopic electrosurgical unit and accessories.
Definition Ablation of prostatic tissue for the treatment of benign prostatic hyperplasia.
Physical State The device consists primarily of a radio frequency generator and an applicator. The applicator is inserted into the urethra and positions the electrodes appropriately for delivery of RF energy transurethrally to the prostate.
Technical Method Radio frequency energy is applied to the prostate using electrodes. Resistive heating of the prostatic tissue leads to necrotic death or direct ablation depending on the temperatures achieved.
Target Area Prostate
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General & Plastic Surgery
Product CodeOEJ
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)
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible