Product Classification

• Device: esophagoscope (flexible or rigid)
• Regulation Description: Esophagoscope (flexible or rigid) 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: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: EOX
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 874.4710
• 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 Standards

• 9-114 IEC 60601-2-18: Edition 3.0 2009-08
  Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
• 9-130 ISO 8600-6 Second edition 2020-09
  Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
• 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
• 9-148 CIE ISO 11664-6 Second edition 2022-08
  Colorimetry - Part 6: CIEDE2000 colour-difference formula

Third Party Review

Not Third Party Eligible