1688 4K Camera Control Unit With Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)

Laparoscope, General & Plastic Surgery

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for 1688 4k Camera Control Unit With Advanced Imaging Modality (1688010000), 1688 4k Pendulum Camera Head (1688310130).

Pre-market Notification Details

Device IDK220895
510k NumberK220895
Device Name:1688 4K Camera Control Unit With Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
ClassificationLaparoscope, General & Plastic Surgery
Applicant Stryker 5900 Optical Court San Jose,  CA  95138
ContactMarlene Fraga
CorrespondentMarlene Fraga
Stryker 5900 Optical Court San Jose,  CA  95138
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-04-22

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