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U.S. Department of Health and Human Services

Product Classification

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Device ureteroscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To perform various diagnostic and therapeutic procedures within the urinary tract.
Physical State endoscope, associated accessories
Technical Method Inserted into blood urinary tract through urethra
Target Area urinary tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFGB
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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