Device, Engorgement, Clitoral

Device Code: 4036

Product Code(s): NBV

Device Classification Information

Device Type ID4036
Device NameDevice, Engorgement, Clitoral
Regulation DescriptionClitoral Engorgement Device.
Regulation Medical SpecialtyObstetrics/Gynecology
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 Type510(k)
CFR Regulation Number884.5970 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNBV
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4036
DeviceDevice, Engorgement, Clitoral
Product CodeNBV
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionClitoral Engorgement Device.
CFR Regulation Number884.5970 [🔎]
TPLC Last Update: 2019-04-02 20:41:59

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