1688 4K Camera Control Unit With Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)

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), Aim 4k Autoclave Camera Head, C-mount (1688410105), Aim 4k Autoclave Coupler, C-mount (1688410110).

Pre-market Notification Details

Device IDK212511
510k NumberK212511
Device Name:1688 4K Camera Control Unit With Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-10
Decision Date2021-11-04

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