Urethroscope

Device Code: 1820

Product Code(s): FGC

Device Classification Information

Device Type ID1820
Device NameUrethroscope
Regulation DescriptionEndoscope And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(k)
CFR Regulation Number876.1500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFGC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID1820
DeviceUrethroscope
Product CodeFGC
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
Device Problems
Material Separation
2
Detachment Of Device Component
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 20:00:07

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