1688 Pendulum 4K Camera Head With Integrated Coupler, 1688 4K Camera Control Unit With Advanced Imaging Modality

Laparoscope, General & Plastic Surgery

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for 1688 Pendulum 4k Camera Head With Integrated Coupler, 1688 4k Camera Control Unit With Advanced Imaging Modality.

Pre-market Notification Details

Device IDK200310
510k NumberK200310
Device Name:1688 Pendulum 4K Camera Head With Integrated Coupler, 1688 4K Camera Control Unit With Advanced Imaging Modality
ClassificationLaparoscope, General & Plastic Surgery
Applicant Stryker 5900 Optical Ct San Jose,  CA  95138
ContactApril Malmborg
CorrespondentApril Malmborg
Stryker 5900 Optical Ct San Jose,  CA  95138
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-06
Decision Date2020-03-06

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