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510(k) Data Aggregation
K Number
K192300Device Name
EnlightenVue Microendoscopy System
Manufacturer
Date Cleared
2020-03-20
(210 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
EnlightenVue, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The enlightenVue Microendoscopy System is intended for visualization of body cavities, hollow organs, and canals. The surgiVue microendoscope is designed to be introduced through natural body cavities or surgical incisions through introducers, trocars, needles, sheaths, or other devices with lumens having inside diameters larger than the outer diameter of the microendoscope.
Device Description
The enlightenVue Microendoscopy System is comprised of the surgiVue microendoscope and surgiTrac laser light source. This system is used to provide imaging capability of internal anatomy for both diagnostic and interventional procedures. The small laser light source focuses light onto a small fiber in the form of white light. The surgiTrac interfaces with the disposable surgiVue microendoscope and a PC to allow for illumination of the captured image.
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