Product Classification

• Device: endoscopic cholangiogram kit
• Regulation Description: Endoscope and accessories.
• Definition: This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
• Physical State: This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
• Technical Method: This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
• Target Area: This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: NWT
• Premarket Review: Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A); Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
• Submission Type: Enforcement Discretion
• 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 Standards

• 9-146 ISO 8600-4 Third Edition 2023-01
  Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
• 9-147 CIE ISO 11664-2 First edition 2022-08
  Colorimetry - Part 2: CIE standard illuminants

Third Party Review

Not Third Party Eligible