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U.S. Department of Health and Human Services

Product Classification

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Device instrument, biopsy
Regulation Description Gastroenterology-urology biopsy instrument.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeKNW
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 876.1075
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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