FDA 510(k) Application Details - K203350

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K203350
Device Name	Endoscopic Irrigation/Suction System
Applicant	Nissha Medical Technologies SAS ZA Des Boutries 12 Rue Des Cayennes Conflans STE Honorine 78700 FR Other 510(k) Applications for this Company
Contact	Roch Mignot Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2020
Decision Date	09/29/2021
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