Adaptor, Ureteral Catheter

Device Code: 1696

Product Code(s): EYI

Device Classification Information

Device Type ID1696
Device NameAdaptor, Ureteral Catheter
Regulation DescriptionUrological 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 Number876.5130 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEYI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1696
DeviceAdaptor, Ureteral Catheter
Product CodeEYI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionUrological Catheter And Accessories.
CFR Regulation Number876.5130 [🔎]
TPLC Last Update: 2019-04-02 19:57:56

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