Tourniquet, Gastro-urology

Device Code: 5499

Product Code(s): EYR

Device Classification Information

Device Type ID5499
Device NameTourniquet, Gastro-urology
Regulation DescriptionNonpneumatic Tourniquet.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type510(K) Exempt
CFR Regulation Number878.5900 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEYR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5499
DeviceTourniquet, Gastro-urology
Product CodeEYR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNonpneumatic Tourniquet.
CFR Regulation Number878.5900 [🔎]
TPLC Last Update: 2019-04-02 21:07:16

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