Bougie, Urological

Device Code: 1732

Product Code(s): FAX

Device Classification Information

Device Type ID1732
Device NameBougie, Urological
Regulation DescriptionUrethral Dilator.
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 Number876.5520 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFAX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1732
DeviceBougie, Urological
Product CodeFAX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionUrethral Dilator.
CFR Regulation Number876.5520 [🔎]
TPLC Last Update: 2019-04-02 19:58:45

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