Product code MJC— Gastroenterology, Urology
BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
- Classification name
- Catheter, Urological (Antimicrobial) And Accessories
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code MJC
FDA has cleared devices under product code MJC between 1994 and 2024, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2004
- 2000
- 1999
- 1998
- 1994
Top applicants under product code MJC
Adverse events under product code MJC
product code MJC- Injury
- 398
- Malfunction
- 12,582
- Other
- 2
- Total
- 12,982
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MJC
- K233094 — Wellead® Latex Foley Catheter
- K040658 — BARDEX I.C. LATEX FOLEY CATHETER
- K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
- K000251 — SPECTRUM SILICONE FOLEY CATHETER
- K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
- K993464 — BARDEX I.C. PEDIATRIC FOLEY CATHETER
- K984136 — BARDEX LUBRI-SIL I.C. FOLEY CATHETER
- K983101 — BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
- K971627 — SILICONE ANTIBACTERIAL FOLEY CATHETER
- K910318 — BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.