Curette, Ear

Device Code: 1495

Product Code(s): JYG

Device Classification Information

Device Type ID1495
Device NameCurette, Ear
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 CodeJYG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1495
DeviceCurette, Ear
Product CodeJYG
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEar, Nose, And Throat Manual Surgical Instrument.
CFR Regulation Number874.4420 [🔎]
Device Problems
Break
1
Tear, Rip Or Hole In Device Packaging
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 19:54:54

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