Camera, Still, Endoscopic

Device Code: 5555

Product Code(s): FXM

Device Classification Information

Device Type ID5555
Device NameCamera, Still, Endoscopic
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)
Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4160 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFXM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5555
DeviceCamera, Still, Endoscopic
Product CodeFXM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSurgical Camera And Accessories.
CFR Regulation Number878.4160 [🔎]
TPLC Last Update: 2019-04-02 21:08:24

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