Product Classification

• Device: sigmoidoscope and accessories, flexible/rigid
• Regulation Description: Endoscope and accessories.
• Definition: to examine and perform procedures within the sigmoid (descending) colon
• Physical State: endoscope, accessories associated with sigmoidoscope
• Technical Method: instrument guided through rectum into the large intestine
• Target Area: sigmoid (descending) colon
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: FAM
• 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: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-389 IEC 60601-2-2 Edition 6.0 2017-03
  Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• 9-94 ISO 8600-4 Second Edition 2014-03-15
  Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
• 9-110 ISO 8600-1 Fourth Edition 2015-10-15
  Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
• 9-123 ISO 8600-3 Second edition 2019-08
  Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
• 9-124 ISO CIE 11664-1:2019
  Colorimetry - Part 1: CIE standard colorimetric observers
• 9-125 CIE ISO 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01
  Colorimetry - Part 2: CIE standard illuminants
• 9-126 CIE ISO 11664-3 First edition 2019-06
  Colorimetry - Part 3: CIE tristimulus values
• 9-127 CIE ISO 11664-4 First edition 2019-06
  Colorimetry - Part 4: CIE 1976 L*a*b* colour space
• 9-128 CIE ISO 11664-6 First edition 2014-02-01
  Colorimetry - Part 6: CIEDE2000 colour-difference formula
• 9-129 CIE ISO 61966-2-1 First edition 1999-10
  Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
• 9-130 ISO 8600-6 Second edition 2020-09
  Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
• 9-131 ISO 8600-5 Second Edition 2020-10
  Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
• 9-139 ISO CIE 11664-5:2016
  Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram
• 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