Device, Measuring, For Panendoscope

Device Code: 1778

Product Code(s): FDY

Device Classification Information

Device Type ID1778
Device NameDevice, Measuring, For Panendoscope
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) Exempt
CFR Regulation Number876.1500 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFDY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1778
DeviceDevice, Measuring, For Panendoscope
Product CodeFDY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
TPLC Last Update: 2019-04-02 19:59:29

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