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FDA 510(k) Application Details - K221098
Device Classification Name
More FDA Info for this Device
510(K) Number
K221098
Device Name
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
Applicant
Stryker Corporation
Boetzinger Strasse 41
Freiburg D-79111 DE
Other 510(k) Applications for this Company
Contact
Maya Schiel
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2022
Decision Date
07/12/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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