Product Classification

• Device: endoscope, ophthalmic
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Ophthalmic
• Product Code: KYH
• Premarket Review: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock ventures
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc