Video Laparoscope, Video Processor, Light Source

Laparoscope, General & Plastic Surgery

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Video Laparoscope, Video Processor, Light Source.

Pre-market Notification Details

Device IDK192918
510k NumberK192918
Device Name:Video Laparoscope, Video Processor, Light Source
ClassificationLaparoscope, General & Plastic Surgery
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 2588538
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeGCJ  
Subsequent Product CodeFET
Subsequent Product CodeNTN
Subsequent Product CodeNWB
Subsequent Product CodePEA
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-15
Decision Date2020-02-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14547410420682 K192918 000
04547410337730 K192918 000

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