Product Classification

• Device: lithotriptor, electro-hydraulic
• Regulation Description: Electrohydraulic lithotriptor.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: FFK
• Submission Type: 510(k)
• Regulation Number: 876.4480
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• 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
• IEC 60601-2-2 2006 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

Guidance Document

• Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; Final

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
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.