Product Classification

• Device: endoscopic irrigation/suction system
• Regulation Description: Endoscope and accessories.
• Definition: To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
• Physical State: may include: pump, motor, tubing, controller, air switch, power supply, transducer, digital display, suction attachment, bottle cap
• Technical Method: Connects to tubing from pump and goes down working channel of endoscope
• Target Area: endoscope
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: OCX
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
• Submission Type: 510(k)
• Regulation Number: 876.1500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 1-158 ISO 10079-4 First edition 2021-08
  Medical suction equipment - Part 4: General requirements

Third Party Review

Not Third Party Eligible