Remover, Intrauterine Device, Contraceptive, Hook-type

Device Code: 3965

Product Code(s): HHF

Device Classification Information

Device Type ID3965
Device NameRemover, Intrauterine Device, Contraceptive, Hook-type
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 CodeHHF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3965
DeviceRemover, Intrauterine Device, Contraceptive, Hook-type
Product CodeHHF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
CFR Regulation Number884.4530 [🔎]
TPLC Last Update: 2019-04-02 20:40:50

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