FDA 510(k) Application Details - K240514

Device Classification Name	Catheter, Suprapubic (And Accessories)   More FDA Info for this Device
510(K) Number	K240514
Device Name	Catheter, Suprapubic (And Accessories)
Applicant	Applied Medical Technology, Inc. 8006 Katherine Blvd. Brecksville, OH 44141 US Other 510(k) Applications for this Company
Contact	Jennifer Hazou Other 510(k) Applications for this Contact
Regulation Number	876.5090   More FDA Info for this Regulation Number
Classification Product Code	KOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2024
Decision Date	11/01/2024
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