E-Brik Visualization Assistant

Anti Fog Solution And Accessories, Endoscopy

JDI Surgical, Inc.

The following data is part of a premarket notification filed by Jdi Surgical, Inc. with the FDA for E-brik Visualization Assistant.

Pre-market Notification Details

Device IDK221293
510k NumberK221293
Device Name:E-Brik Visualization Assistant
ClassificationAnti Fog Solution And Accessories, Endoscopy
Applicant JDI Surgical, Inc. 9925 Silver Maple Way Highlands Ranch,  CO  80129
ContactDwight Lenox
CorrespondentSrividya Pothana
University Of Utah 10 North 1900 East, EHSL Rm. 22B Salt Lake City,  UT  84112
Product CodeOCT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-04
Decision Date2022-07-07

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