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U.S. Department of Health and Human Services

Product Classification

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Device duodenoscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To examine the duodenum and to perform various procedures within the duodenum.
Physical State endoscope, accessories associated with duodenoscope
Technical Method Inserted orally into duodenum
Target Area duodenum, esophagus
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFDT
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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