Set, Anesthesia, Paracervical

Device Code: 3904

Product Code(s): HEE

Device Classification Information

Device Type ID3904
Device NameSet, Anesthesia, Paracervical
Regulation DescriptionObstetric Anesthesia Set.
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 Number884.5100 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHEE
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 ID3904
DeviceSet, Anesthesia, Paracervical
Product CodeHEE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionObstetric Anesthesia Set.
CFR Regulation Number884.5100 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
CooperSurgical, Inc.
III Oct-06-2015
TPLC Last Update: 2019-04-02 20:39:49

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