Sound, Metal, Interconnected

Device Code: 1741

Product Code(s): FBS

Device Classification Information

Device Type ID1741
Device NameSound, Metal, Interconnected
Regulation DescriptionInterlocking Urethral Sound.
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) Exempt
CFR Regulation Number876.4590 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFBS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1741
DeviceSound, Metal, Interconnected
Product CodeFBS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionInterlocking Urethral Sound.
CFR Regulation Number876.4590 [🔎]
TPLC Last Update: 2019-04-02 19:58:52

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