Product Classification

• Device: gastroscope and accessories, flexible/rigid
• Regulation Description: Endoscope and accessories.
• Definition: To examine or perform procedures in the stomach.
• Physical State: endoscope, accessories associated with gastroscope
• Technical Method: Inserted orally into the stomach
• Target Area: stomach
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: FDS
• 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 60601-2-2 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

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.