TGS Guidewire And Updated Scopis Software

Ear, Nose, And Throat Stereotaxic Instrument

Stryker ENT

The following data is part of a premarket notification filed by Stryker Ent with the FDA for Tgs Guidewire And Updated Scopis Software.

Pre-market Notification Details

Device IDK193118
510k NumberK193118
Device Name:TGS Guidewire And Updated Scopis Software
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth,  MN  55447
ContactBruce Backlund
CorrespondentBruce Backlund
Stryker ENT 3600 Holly Lane North, Suite 40 Plymouth,  MN  55447
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-12
Decision Date2020-02-21

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