FDA Product Code MJC: Catheter, Urological (antimicrobial) And Accessories
Leading manufacturers include C.R. Bard, Inc., Cook Urological, Inc. and Well Lead Medical (Hainan) Co., Ltd..
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
Aug 30, 2000
SPECTRUM SILICONE FOLEY CATHETER
Cook Urological, Inc.
Gastroenterology & Urology
216d
Cleared
Dec 10, 1999
BARDEX I.C. PEDIATRIC FOLEY CATHETER
C.R. Bard, Inc.
Gastroenterology & Urology
58d
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
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.