Product Classification

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

Recognized Consensus Standard

• ASTM F 1992 -99 (Reapproved 2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes

Guidance Documents

• Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology
• Convenience Kits Interim Regulatory Guidance

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.