Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source With Adavanced Imaging Modality)

Laparoscope, General & Plastic Surgery

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Adavanced Imaging Modality System (1688 4k Camera System With Advanced Imaging Modality, L11 Led Light Source With Adavanced Imaging Modality).

Pre-market Notification Details

Device IDK202592
510k NumberK202592
Device Name:Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source With Adavanced Imaging Modality)
ClassificationLaparoscope, General & Plastic Surgery
Applicant Stryker 5900 Optical Ct San Jose,  CA  95138
ContactDivya Sekar
CorrespondentDivya Sekar
Stryker 5900 Optical Ct San Jose,  CA  95138
Product CodeGCJ  
Subsequent Product CodeFCS
Subsequent Product CodeFCW
Subsequent Product CodeOWN
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-08
Decision Date2020-10-08

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.