HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT— 510(k) K033477

Clearance details

Applicant

Rochester Medical Corp.

Product code

Code MJC

Device class

Class 2

Regulation

21 CFR 876.5130

Advisory panel

Gastroenterology, Urology

Date received

2003-11-03

Decision date

2004-06-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stewartville, MN, US

• K233094 — Wellead® Latex Foley Catheter2024-06-06
• K040658 — BARDEX I.C. LATEX FOLEY CATHETER2004-09-29
• K000251 — SPECTRUM SILICONE FOLEY CATHETER2000-08-30
• K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER2000-07-07
• K993464 — BARDEX I.C. PEDIATRIC FOLEY CATHETER1999-12-10

• K122785 — HYDROSIL; MAGIC; PERSONAL CATHETER2013-05-14
• K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)2000-05-19
• K981612 — ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER1998-07-08
• K971627 — SILICONE ANTIBACTERIAL FOLEY CATHETER1998-01-13
• K970704 — PERSONAL CATHETER1997-03-13

Injury

398

Malfunction

12,582

Other

2

Total

12,982

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-3226-2017 — Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.Class II·Terminated·C.R. Bard, Inc.·20170728
• Z-0600-2017 — Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter has an antibacterial and hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. It is packaged with a water sachet that is manually burst to hydrate the catheter coating at time of use. The catheters are packaged in a film-to-film pouch and are sterilized by electron beam irradiation and are distributed as a single use device. The catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction and surgical procedures. Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established. The device is not intended to be used as a treatment for active urinary tract infection. For urological use only; urinary catheters are intended for use for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.Class II·Terminated·C.R. Bard, Inc.·20161005
• Z-0198-2016 — Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 unitsClass III·Terminated·C.R. Bard, Inc.·20151002

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033477.