FDA 510(k) Applications for Medical Device Product Code: HFN (Transducer, Pressure, Intrauterine)

FDA 510(k) Applications for Medical Device Product Code "HFN"
(Transducer, Pressure, Intrauterine)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K250897	Clinical Innovations LLC	Koala Intrauterine Pressure Catheter (IPC-5000E)	05/22/2025
K974389	CLINICAL INNOVATIONS, INC.	KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER	02/19/1998
K973746	CLINICAL INNOVATIONS, INC.	PRE-FILLED SYRINGE FOR KOALA IUP	11/24/1997
K954955	CLINICAL INNOVATIONS, INC.	STORC INTRAUTERINE PRESSURE CATHETER	04/17/1996
K961424	UTAH MEDICAL PRODUCTS, INC.	INTRAN 500	07/10/1996
K955443	UTAH MEDICAL PRODUCTS, INC.	INTRAN PLUS	02/20/1996