Catheters, Salpingography

Device Code: 4022

Product Code(s): MOV

Device Classification Information

Device Type ID4022
Device NameCatheters, Salpingography
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)
CFR Regulation Number884.4530 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMOV
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4022
DeviceCatheters, Salpingography
Product CodeMOV
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionObstetric-gynecologic Specialized Manual Instrument.
CFR Regulation Number884.4530 [🔎]
Premarket Reviews
ManufacturerDecision
COOK, INC.
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Material Separation
3
Device Operates Differently Than Expected
1
Total Device Problems 4
Recalls
Manufacturer Recall Class Date Posted
1
Cook Inc.
II Aug-22-2016
TPLC Last Update: 2019-04-02 20:41:47

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