Needle, Cerclage, Gynecological

Device Code: 3884

Product Code(s): HDH

Device Classification Information

Device Type ID3884
Device NameNeedle, Cerclage, Gynecological
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 CodeHDH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3884
DeviceNeedle, Cerclage, Gynecological
Product CodeHDH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
CFR Regulation Number884.4530 [🔎]
TPLC Last Update: 2019-04-02 20:39:27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.