Product Classification

• Device: transurethral occlusion insert, urinary incontinence-control, female
• Definition: Transurethral insert for urinary occlusion/control in women with urinary incontinence
• Physical State: balloon tipped catheter, insertion device
• Technical Method: A balloon tipped catheter is inserted into the urethra. Deflation or removal of the device results in fluid movement
• Target Area: urethra
• Review Panel: Gastroenterology/Urology
• Product Code: OCK
• Premarket Review: Reproductive, Gynecology and Urology Devices (DHT3B); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: PMA
• Device Class: 3
• 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