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FDA 510(k) Application Details - K210625
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K210625
Device Name
Endoscope Channel Accessory
Applicant
FUJIFILM medwork GmbH
Medworkring 1
Hochstadt 91315 DE
Other 510(k) Applications for this Company
Contact
Randy Vader
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
ODC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/02/2021
Decision Date
09/10/2021
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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