FDA 510(k) Application Details - K241858

Device Classification Name	More FDA Info for this Device
510(K) Number	K241858
Device Name	BARS Set (100.60)
Applicant	Ovesco Endoscopy AG Friedrich-Miescher-Strasse 9 Tuebingen 72076 DE Other 510(k) Applications for this Company
Contact	Antonio Caputo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2024
Decision Date	08/26/2024
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