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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 Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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