STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source And IRIS Ureteral Kit]

Light, Catheter, Fiberoptic, Glass, Ureteral

Stryker Endoscopy

The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Infrared Illumination System (iris) [aim Light Source And Iris Ureteral Kit].

Pre-market Notification Details

Device IDK151243
510k NumberK151243
Device Name:STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source And IRIS Ureteral Kit]
ClassificationLight, Catheter, Fiberoptic, Glass, Ureteral
Applicant Stryker Endoscopy 5900 Optical Ct San Jose,  CA  95138
ContactGolnaz Moeini
CorrespondentGolnaz Moeini
Stryker Endoscopy 5900 Optical Ct San Jose,  CA  95138
Product CodeFCS  
CFR Regulation Number876.4020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-11
Decision Date2015-08-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
37613327174817 K151243 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.