Product Classification

• Device: mini endoscope, gastroenterology-urology
• Regulation Description: Endoscope and accessories.
• Definition: To examine and perform procedures in body cavities of the gi and gu tract.
• Physical State: May include: handle, scope, fiberoptic attachment. Usually modular in nature. May be custom built
• Technical Method: Can be placed through working channel of a full sized endoscope. May also be used as a stand alone device
• Target Area: various body cavities in the GI and GU tract
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: ODF
• 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
• ASTM F 1992 -99 (Reapproved 2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes

Third Party Review

Not Third Party Eligible