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U.S. Department of Health and Human Services

Product Classification

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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 CodeOCQ
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(k)
Regulation Number 884.1720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070852.htm] 
Third Party Review Not Third Party Eligible
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