Aspirator, Endocervical

Device Code: 3924

Product Code(s): HFC

Device Classification Information

Device Type ID3924
Device NameAspirator, Endocervical
Regulation DescriptionEndocervical Aspirator.
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 Number884.1050 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHFC
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 ID3924
DeviceAspirator, Endocervical
Product CodeHFC
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndocervical Aspirator.
CFR Regulation Number884.1050 [🔎]
TPLC Last Update: 2019-04-02 20:40:09

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