FDA 510(k) Application Details - K233442

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K233442
Device Name	Endoscopic Irrigation/Suction System
Applicant	Biotex, Inc. 114 Holmes Rd. Houston, TX 77045 US Other 510(k) Applications for this Company
Contact	Wade Munsch 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	10/18/2023
Decision Date	05/21/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review