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U.S. Department of Health and Human Services

Product Classification

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Device endoscopic guidewire, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
Physical State metal guidewire with or without polymer coating, and associated guidewire accessories
Technical Method placed through working channel of endoscope
Target Area various in GI and GU tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeOCY
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 Standard
Third Party Review
Accredited Persons

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