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U.S. Department of Health and Human Services

Product Classification

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Device dislodger, stone, flexible, ureteral, reprocessed
Regulation Description Ureteral stone dislodger.
Definition A ureteral stone dislodger is a device that consists of a bougie or a catheter with a special flexible tip.It is inserted through a cystoscope and used to entrap and remove stones from the ureter.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNQT
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 876.4680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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