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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
    Note: FDA intends to propose exempting these devices from premarket notification pursuant to the criteria at sections 510(l) and 510(m) of the FD&C Act, subject to limitations on exemption criteria found in .9 of the associated classification regulation. Until the publication of a final rule or order exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons