Washer, Endometrial

Device Code: 3925

Product Code(s): HFD

Device Classification Information

Device Type ID3925
Device NameWasher, Endometrial
Regulation DescriptionEndometrial Washer.
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 Number884.1185 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHFD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID3925
DeviceWasher, Endometrial
Product CodeHFD
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndometrial Washer.
CFR Regulation Number884.1185 [🔎]
TPLC Last Update: 2019-04-02 20:40:10

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