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U.S. Department of Health and Human Services

Product Classification

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Device dislodger, stone, biliary
Regulation Description Biliary catheter and accessories.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeLQR
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 876.5010
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080794.pdf] 
Third Party Review
Accredited Persons

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