FDA 510(k) Application Details - K230319

Device Classification Name	More FDA Info for this Device
510(K) Number	K230319
Device Name	Passio Pump Drainage System
Applicant	Bearpac Medical 124 West Point Road Moultonborough, NH 03254 US Other 510(k) Applications for this Company
Contact	Jay Zimmerman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2023
Decision Date	11/24/2023
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review