Loupe, Diagnostic/surgical

Device Code: 5513

Product Code(s): FSP

Device Classification Information

Device Type ID5513
Device NameLoupe, Diagnostic/surgical
Regulation DescriptionManual Surgical Instrument For General Use.
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 One - Light Based/Laser (GSDB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFSP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5513
DeviceLoupe, Diagnostic/surgical
Product CodeFSP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Surgical Instrument For General Use.
CFR Regulation Number878.4800 [🔎]
Device Problems
Improper Or Incorrect Procedure Or Method
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 21:07:35

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