FDA 510(k) Application Details - K201861

Device Classification Name	Colonic Irrigation System   More FDA Info for this Device
510(K) Number	K201861
Device Name	Colonic Irrigation System
Applicant	Gnali Bocia S.R.L. Via Brescia, 41/M-N Lumezzane 25065 IT Other 510(k) Applications for this Company
Contact	Katy Gnali Other 510(k) Applications for this Contact
Regulation Number	876.5220   More FDA Info for this Regulation Number
Classification Product Code	KPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2020
Decision Date	03/02/2022
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