FDA 510(k) Application Details - K220884

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K220884
Device Name	Endoscope Channel Accessory
Applicant	SML Med-Tech Solutions Limited Rm 406, Wah Yiu Indl Ctr, 30-32 Au Pui Wan St Fo Tan, N.T. CN Other 510(k) Applications for this Company
Contact	Mark Ko 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	03/28/2022
Decision Date	01/17/2023
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