Elevator, Uterine

Device Code: 3892

Product Code(s): HDP

Device Classification Information

Device Type ID3892
Device NameElevator, Uterine
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
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 Number884.4530 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHDP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID3892
DeviceElevator, Uterine
Product CodeHDP
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
CFR Regulation Number884.4530 [🔎]
TPLC Last Update: 2019-04-02 20:39:36

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