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FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Class II

FDA Device Classification

Classification Details

Product Code
FCM
Device Class
Class II
Regulation Number
876.5130
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250891convatec limitedCure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure CatheteJune 6, 2025
K223821coloplastSelf-Cath Closed SystemAugust 2, 2023
K082831amsino internationalAMSELF CLOSED CATHETERIZATION SYSTEMOctober 23, 2008
K070939coloplast manufacturing usSELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMJune 1, 2007
K070048marian medicalGUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarch 15, 2007
K030664amsino internationalAMSURE FOLEY INSERTION TRAYMay 23, 2003
K030712amsino internationalAMSURE URETHRAL CATHETERIZATION TRAYMay 23, 2003
K011055go medical industries pty.THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADSJune 6, 2001
K010420ruschRUSCH MMG/O'NEIL CATHETERMay 9, 2001
K003873mentorMENTOR SELF-CATH CLOSED SYSTEMMarch 29, 2001
K002803go medical industries pty.THE O'NEIL STERILE FIELD URINARY CATHETER KITDecember 27, 2000
K983010rusch intlSELF CATH SET/SAFETY CATHFebruary 12, 1999
K963993ruschRUSCH SIMPLASTIC FOLEY CATHETERIZATION SETDecember 17, 1996
K962254national healthcare mfgNHMC URETHRAL CATHETERIZATION TRAYJuly 29, 1996
K962073continental medical laboratoriesURETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAYJune 21, 1996
K961442customedUNIVERSAL DRAINAGE TRAYMay 9, 1996
K960215custom pack reliabilityCPR URETHRAL CATHETER TRAYApril 1, 1996
K960214custom pack reliabilityCPR FOLEY CAHTETER KITApril 1, 1996
K960566national healthcare mfgNHMC FOLEY CATHETERIZATION TRAYFebruary 29, 1996
K951479trinity laboratoriesCATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLEJune 15, 1995