Trocar, Gastro-urology

Device Code: 5452

Product Code(s): FBQ

Device Classification Information

• Device Type ID: 5452
• Device Name: Trocar, Gastro-urology
• Regulation Description: Suprapubic Urological Catheter And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: General & Plastic Surgery
• 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) Exempt
• CFR Regulation Number: 876.5090 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FBQ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5452
• Device: Trocar, Gastro-urology
• Product Code: FBQ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Suprapubic Urological Catheter And Accessories.
• CFR Regulation Number: 876.5090 [🔎]

Device Problems
Material Separation	1
Break	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 21:06:28