Product Classification

• Device: applicator, transurethral, radio frequency, for stress urinary incontinence in women
• Regulation Description: Electrosurgical cutting and coagulation device and accessories.
• Definition: Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility.
• Physical State: Consists of radio frequency probe and generator and accessories.
• Technical Method: Functions within a system.
• Target Area: Bladder neck and proximal urethra
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: NVJ
• Premarket Review: General Surgery Devices (DHT4A); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 878.4400
• 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

• Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible