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U.S. Department of Health and Human Services

Product Classification

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Device kit, catheter, external, male (excludes hiv testing)
Regulation Description Urological catheter and accessories.
Definition Male external catheterization kit (excludes hiv testing).
Physical State Male External Catheterization Kit (Excludes HIV Testing)
Technical Method Male External Catheterization Kit (Excludes HIV Testing)
Target Area Male External Catheterization Kit (Excludes HIV Testing)
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNWQ
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 876.5130
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Convenience Kits Interim Regulatory Guidance
Third Party Review Not Third Party Eligible
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