FDA 510(k) Application Details - K242134

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K242134
Device Name	Endoscopic Irrigation/Suction System
Applicant	FINEMEDIX Co., Ltd. 140-9, Yuram-Ro, Dong-Gu Daegu 41059 KR Other 510(k) Applications for this Company
Contact	Seok-Jun Ma 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	07/22/2024
Decision Date	08/20/2024
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