Camera, Cine, Microsurgical, Without Audio

Device Code: 5543

Product Code(s): FWJ

Device Classification Information

Device Type ID5543
Device NameCamera, Cine, Microsurgical, Without Audio
Regulation DescriptionSurgical Camera And Accessories.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type510(K) Exempt
CFR Regulation Number878.4160 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFWJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5543
DeviceCamera, Cine, Microsurgical, Without Audio
Product CodeFWJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSurgical Camera And Accessories.
CFR Regulation Number878.4160 [🔎]
TPLC Last Update: 2019-04-02 21:08:12

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