FDA 510(k) Application Details - K221264

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K221264
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	05/02/2022
Decision Date	06/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review