FUJIFILM Video Laparoscope

Laparoscope, General & Plastic Surgery

Fujifilm Corporation

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

Pre-market Notification Details

Device IDK202130
510k NumberK202130
Device Name:FUJIFILM Video Laparoscope
ClassificationLaparoscope, General & Plastic Surgery
Applicant Fujifilm Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentKamila Sak
Fujifilm Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-31
Decision Date2020-08-20

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