Product Classification

• Device: esophagoscope, rigid, gastro-urology
• Regulation Description: Endoscope and accessories.
• Definition: If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: FDW
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); 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: Ineligible
• 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