Product Classification

• Device: laparoscope, general & plastic surgery
• Regulation Description: Endoscope and accessories.
• Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 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: General & Plastic Surgery
• Product Code: GCJ
• Premarket Review: Surgical and Infection Control Devices (OHT4); General Surgery Devices (DHT4A)
• 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 Standards

• 9-39 ISO 8600-5 First edition 2005-03-15
  Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
• 9-40 ISO 8600-6 First edition 2005-03-15
  Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
• 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

Third Party Review

Not Third Party Eligible