Instrument, Catheter, Punch

Device Code: 1796

Product Code(s): FEX

Device Classification Information

Device Type ID1796
Device NameInstrument, Catheter, Punch
Regulation DescriptionSuprapubic Urological Catheter 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) Exempt
CFR Regulation Number876.5090 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFEX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1796
DeviceInstrument, Catheter, Punch
Product CodeFEX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSuprapubic Urological Catheter And Accessories.
CFR Regulation Number876.5090 [🔎]
TPLC Last Update: 2019-04-02 19:59:45

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