Product Classification

• 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 Code: OEJ
• 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 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