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U.S. Department of Health and Human Services

Product Classification

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Device kit, catheter, cystostomy, suprapubic
Regulation Description Suprapubic urological catheter and accessories.
Definition Suprapubic cystostomy catheter kit.
Physical State Suprapubic Cystostomy Catheter Kit
Technical Method Suprapubic Cystostomy Catheter Kit
Target Area Suprapubic Cystostomy Catheter Kit
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNWP
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 876.5090
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Convenience Kits Interim Regulatory Guidance
Third Party Review Not Third Party Eligible
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