Product Classification

• Device: laparoscopic bladder-neck suspension instrument, stress urinary incontinence
• Regulation Description: Gynecologic laparoscope and accessories.
• Definition: For female urinary stress incontinence due to hypermobility
• Physical State: may include: template assembly, suture retriever, suture cutter, suture placement system
• Technical Method: Bladder neck suspension using sutures
• Target Area: bladder neck
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Gastroenterology/Urology
• Product Code: OCQ
• Premarket Review: Reproductive, Gynecology and Urology Devices (DHT3B); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: 510(k)
• Regulation Number: 884.1720
• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc