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U.S. Department of Health and Human Services

Product Classification
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Device endoscopic access overtube, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Physical State overtube
Technical Method Endoscope inserted and advanced through center of device
Target Area various openings in gi and gu tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFED
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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