Product Classification

• Device: tripsor, stone, bladder
• Regulation Description: Mechanical lithotriptor.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: FGK
• Submission Type: 510(k)
• Regulation Number: 876.4500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology  

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.