Prosthesis, Fallopian Tube

Device Code: 3931

Product Code(s): HFJ

Device Classification Information

Device Type ID3931
Device NameProsthesis, Fallopian Tube
Regulation DescriptionFallopian Tube Prosthesis.
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 Number884.3650 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHFJ
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3931
DeviceProsthesis, Fallopian Tube
Product CodeHFJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionFallopian Tube Prosthesis.
CFR Regulation Number884.3650 [🔎]
Device Problems
Migration Or Expulsion Of Device
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:40:16

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