Fluid, Hysteroscopy

Device Code: 4114

Product Code(s): LTA

Device Classification Information

Device Type ID4114
Device NameFluid, Hysteroscopy
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeLTA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4114
DeviceFluid, Hysteroscopy
Product CodeLTA
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:43:15

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