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U.S. Department of Health and Human Services

Product Classification

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Device endoscope maintenance system
Regulation Description Endoscope and accessories.
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 Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible