FDA 510(k) Application Details - K233591

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K233591
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	Degania Silicone Ltd. Degania Bet 1513000 Degania Bet 1513000 IL Other 510(k) Applications for this Company
Contact	Tali Raz Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2023
Decision Date	05/31/2024
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