Camera, Television, Microsurgical, With Audio

Device Code: 5538

Product Code(s): FWE

Device Classification Information

Device Type ID5538
Device NameCamera, Television, Microsurgical, With 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 CodeFWE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5538
DeviceCamera, Television, Microsurgical, With Audio
Product CodeFWE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSurgical Camera And Accessories.
CFR Regulation Number878.4160 [🔎]
TPLC Last Update: 2019-04-02 21:08:07

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