Trocar, Tracheal

Device Code: 1571

Product Code(s): KCI

Device Classification Information

Device Type ID1571
Device NameTrocar, Tracheal
Regulation DescriptionEar, Nose, And Throat Manual Surgical Instrument.
Regulation Medical SpecialtyEar Nose & Throat
Review PanelEar Nose & Throat
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Ear, Nose, And Throat Devices Branch (ENTB)
Submission Type510(K) Exempt
CFR Regulation Number874.4420 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKCI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1571
DeviceTrocar, Tracheal
Product CodeKCI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEar, Nose, And Throat Manual Surgical Instrument.
CFR Regulation Number874.4420 [🔎]
TPLC Last Update: 2019-04-02 19:56:00

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