Product Classification

• Device: kit, catheter, urinary (exludes hiv testing)
• Regulation Description: Urological catheter and accessories.
• Definition: Urinary Catheterization Kit (Excludes HIV Testing)
• Physical State: Urinary Catheterization Kit (Excludes HIV Testing)
• Technical Method: Urinary Catheterization Kit (Excludes HIV Testing)
• Target Area: Urinary Catheterization Kit (Excludes HIV Testing)
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: NWO
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: 510(k)
• Regulation Number: 876.5130
• 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

Recognized Consensus Standard

• 9-132 ASTM F623-19
  Standard Performance Specification for Foley Catheter

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc