Scissors, Episiotomy

Device Code: 3887

Product Code(s): HDK

Device Classification Information

Device Type ID3887
Device NameScissors, Episiotomy
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 CodeHDK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3887
DeviceScissors, Episiotomy
Product CodeHDK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionObstetric-gynecologic General Manual Instrument.
CFR Regulation Number884.4520 [🔎]
TPLC Last Update: 2019-04-02 20:39:30

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