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U.S. Department of Health and Human Services

Product Classification

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Device endoscopic cytology brush
Regulation Description Endoscope and accessories.
Definition To collect cells for cytological evaluation.
Physical State brush and shaft
Technical Method Brush goes through endoscope to desired location and rotates to remove and collect cells.
Target Area various tissues in gi and gu tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeFDX
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
Guidance Document
  • Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology
Third Party Review
Accredited Persons

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