Product Classification

• Device: instrument, biopsy, suction
• Regulation Description: Gastroenterology-urology biopsy instrument.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: FCK
• Submission Type: 510(k)
• Regulation Number: 876.1075
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Guidance for the Content of Premarket Notifications for Biopsy Devices 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.