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U.S. Department of Health and Human Services

Product Classification

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Device kit, choledochoscope, flexible and rigid
Regulation Description Endoscope and accessories.
Definition Flexible and rigid choledochoscope kit.
Physical State Flexible and Rigid Choledochoscope Kit
Technical Method Flexible and Rigid Choledochoscope Kit
Target Area Flexible and Rigid Choledochoscope Kit
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNWS
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 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Convenience Kits Interim Regulatory Guidance
Third Party Review Not Third Party Eligible
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