Kit, Catheter, External, Male (excludes Hiv Testing)

Device Code: 2052

Product Code(s): NWQ

Definition: Male External Catheterization Kit (Excludes HIV Testing)

Device Classification Information

• Device Type ID: 2052
• Device Name: Kit, Catheter, External, Male (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 Description: Urological Catheter And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• 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)
• CFR Regulation Number: 876.5130 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NWQ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 9-44 ASTM F623 -99 (Reapproved 2013)
  Standard Performance Specification For Foley Catheter

Total Product Life Cycle

• Device Type ID: 2052
• Device: Kit, Catheter, External, Male (excludes Hiv Testing)
• Product Code: NWQ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Urological Catheter And Accessories.
• CFR Regulation Number: 876.5130 [🔎]

TPLC Last Update: 2019-04-02 20:05:04