Curette, Uterine

Device Code: 3875

Product Code(s): HCY

Device Classification Information

Device Type ID3875
Device NameCurette, 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) Exempt
CFR Regulation Number884.4530 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHCY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3875
DeviceCurette, Uterine
Product CodeHCY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
CFR Regulation Number884.4530 [🔎]
Device Problems
Material Fragmentation
1
Break
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 20:39:14

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