Product Classification

• Device: electrosurgical radiofrequency system, stress urinary incontinence, female, transvaginal or laparoscopic, pelvic tissue
• Regulation Description: Electrosurgical cutting and coagulation device and accessories.
• Definition: For shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence
• Physical State: radiofrequency generator, applicator, software
• Technical Method: A generator supplies radiofrequency energy through a connected applicator with an electrode tip
• Target Area: pelvic tissue
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: Gastroenterology/Urology
• Product Code: MUK
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Reproductive, Gynecology and Urology Devices (DHT3B)
• 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