Product Classification

• 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 Code: NWS
• Premarket Review: Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A); Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
• Submission Type: 510(k)
• Regulation Number: 876.1500
• 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

Recognized Consensus Standard

• 9-146 ISO 8600-4 Third Edition 2023-01
  Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion

Third Party Review

Not Third Party Eligible