Instrument, Manual, General Obstetric-gynecologic

Device Code: 4001

Product Code(s): KOH

Device Classification Information

Device Type ID4001
Device NameInstrument, Manual, General Obstetric-gynecologic
Regulation DescriptionObstetric-gynecologic General 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 Number884.4520 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKOH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4001
DeviceInstrument, Manual, General Obstetric-gynecologic
Product CodeKOH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionObstetric-gynecologic General Manual Instrument.
CFR Regulation Number884.4520 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
63
Material Split, Cut Or Torn
1
Device Contamination With Chemical Or Other Material
1
Total Device Problems 65
TPLC Last Update: 2019-04-02 20:41:28

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