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FDA 510(k) Application Details - K233425
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K233425
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
Sutter Medizintechnik GmbH
Alfred-Walz-Str. 22
Emmendingen 79312 DE
Other 510(k) Applications for this Company
Contact
Simone Peschl
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
GEI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2023
Decision Date
01/25/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K233425
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