Electrocautery, Endoscopic And Accessories

Device Code: 3988

Product Code(s): HIM

Device Classification Information

Device Type ID3988
Device NameElectrocautery, Endoscopic And Accessories
Regulation DescriptionEndoscopic Electrocautery And Accessories.
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 Number884.4100 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHIM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3988
DeviceElectrocautery, Endoscopic And Accessories
Product CodeHIM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscopic Electrocautery And Accessories.
CFR Regulation Number884.4100 [🔎]
TPLC Last Update: 2019-04-02 20:41:15

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