Instrument, Destructive, Fetal, Obstetric

Device Code: 3994

Product Code(s): KNB

Device Classification Information

Device Type ID3994
Device NameInstrument, Destructive, Fetal, Obstetric
Regulation DescriptionObstetric Fetal Destructive 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 Number884.4500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKNB
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 ID3994
DeviceInstrument, Destructive, Fetal, Obstetric
Product CodeKNB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionObstetric Fetal Destructive Instrument.
CFR Regulation Number884.4500 [🔎]
TPLC Last Update: 2019-04-02 20:41:21

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