Stryker CrossFlow Integrated Arthroscopy Pump

Arthroscope

Stryker Corp.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Crossflow Integrated Arthroscopy Pump.

Pre-market Notification Details

Device IDK191259
510k NumberK191259
Device Name:Stryker CrossFlow Integrated Arthroscopy Pump
ClassificationArthroscope
Applicant Stryker Corp. 5900 Optical Ct San Jose,  CA  95138
ContactJustin Florence
CorrespondentJustin Florence
Stryker Corp. 5900 Optical Ct San Jose,  CA  95138
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-10
Decision Date2019-07-12

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