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U.S. Department of Health and Human Services

Product Classification
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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 CodeOCX
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
Third Party Review Not Third Party Eligible
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