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U.S. Department of Health and Human Services

Product Classification

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Device endoscope maintenance system
Definition To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments.
Physical State Wall-mounted tube for holding disinfectant solution and endoscope insertion tubes and accessories
Technical Method The device consists of wall-mounted vertical tubes made of clear seamless PVC that hold endoscope insertion tubes or similar elongated instruments and accessories during disinfection and rinsing. After draining the solution and rinse water, the tube is used to store the endoscope and accessories.
Target Area Endoscopes and disinfectant solution
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General Hospital
Product CodePUP
Premarket Review Infection Control and Plastic Surgery Devices (DHT4B)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(K) Exempt
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible