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U.S. Department of Health and Human Services

Product Classification
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Device endoscopic video imaging system/component, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Physical State May include: ccd camera, monitor, other software or hardware associated with video equipment, and components from other regulations, such as a pump.
Technical Method Inserted through endoscope
Target Area various body cavities, hollow organs, and canals in GI and GU tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeOCS
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
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 Standards
Third Party Review Not Third Party Eligible
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