Product Classification

• Device: duodenoscope and accessories, flexible/rigid
• Regulation Description: Endoscope and accessories.
• Definition: To examine the duodenum and to perform various procedures within the duodenum.
• Physical State: endoscope, accessories associated with duodenoscope
• Technical Method: Inserted orally into duodenum
• Target Area: duodenum, esophagus
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: FDT
• Submission Type: 510(k)
• Regulation Number: 876.1500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 60601-2-18 (1996) Amendment 1 2000 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
• IEC 60601-2-2 2006 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
• IEC 60601-2-2 Edition 5.0 2009-02 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
• AAMI/ANSI/IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories
• ISO 8600-4 First edition 1997-07-01 Optics and optical instruments -- Medical endoscopes and certain accessories -- Part 4: Determination of maximum width of insertion portion
• ISO 8600-1 Second edition 2005-05-01 Optics and photonics -- Medical endoscopes and endotherapy devices -- Part 1: General requirements
• 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
• ISO 8600-6 First edition 2005-03-15 Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
• ISO 8600-3 First edition 1997-07-01 Optics and Optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
• ISO 8600-3 First edition 1997-07-01 AMENDMENT 1 Optics and optical instruments - Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics`
• 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

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.