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FDA 510(k) Application Details - K230780
Device Classification Name
Stimulator, Electrical, Non-Implantable, For Incontinence
More FDA Info for this Device
510(K) Number
K230780
Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant
Zimmer MedizinSysteme GmbH
Junkersstrasse 9
Neu-Ulm 89231 DE
Other 510(k) Applications for this Company
Contact
Ute Killet
Other 510(k) Applications for this Contact
Regulation Number
876.5320
More FDA Info for this Regulation Number
Classification Product Code
KPI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/2023
Decision Date
10/05/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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