FDA Product Code MJC: Catheter, Urological (antimicrobial) And Accessories
Leading manufacturers include C.R. Bard, Inc., Rochester Medical Corp. and Cook Urological, Inc..
10
Total
10
Cleared
275d
Avg days
1994
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Catheter, Urological (antimicrobial) And Accessories Devices (Product Code MJC)
10 devices
Cleared
Jun 06, 2024
Wellead® Latex Foley Catheter
Well Lead Medical (Hainan) Co., Ltd.
Gastroenterology & Urology
254d
Cleared
Sep 29, 2004
BARDEX I.C. LATEX FOLEY CATHETER
C.R. Bard, Inc.
Gastroenterology & Urology
201d
Cleared
Jun 10, 2004
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
Rochester Medical Corp.
Gastroenterology & Urology
220d
Cleared
Aug 30, 2000
SPECTRUM SILICONE FOLEY CATHETER
Cook Urological, Inc.
Gastroenterology & Urology
216d
Cleared
Jul 07, 2000
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
Rochester Medical Corp.
Gastroenterology & Urology
88d
Cleared
Dec 10, 1999
BARDEX I.C. PEDIATRIC FOLEY CATHETER
C.R. Bard, Inc.
Gastroenterology & Urology
58d
Cleared
Feb 16, 1999
BARDEX LUBRI-SIL I.C. FOLEY CATHETER
Bard Medical Div.
Gastroenterology & Urology
90d
Cleared
Nov 03, 1998
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
C.R. Bard, Inc.
Gastroenterology & Urology
61d
Cleared
Jan 13, 1998
SILICONE ANTIBACTERIAL FOLEY CATHETER
Rochester Medical Corp.
Gastroenterology & Urology
256d
Cleared
Aug 18, 1994
BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
C.R. Bard, Inc.
Gastroenterology & Urology
1302d
About Product Code MJC - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code MJC since 1994, with 10 receiving FDA clearance (average review time: 275 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.