MJC — Catheter, Urological (Antimicrobial) And Accessories Class II
FDA product code MJC covers "Catheter, Urological (Antimicrobial) And Accessories", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MJC
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233094 | well lead medical (hainan) co | Wellead® Latex Foley Catheter | June 6, 2024 |
| K040658 | c.r. bard | BARDEX I.C. LATEX FOLEY CATHETER | September 29, 2004 |
| K033477 | rochester medical | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SY | June 10, 2004 |
| K000251 | cook urological | SPECTRUM SILICONE FOLEY CATHETER | August 30, 2000 |
| K001143 | rochester medical | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | July 7, 2000 |
| K993464 | c.r. bard | BARDEX I.C. PEDIATRIC FOLEY CATHETER | December 10, 1999 |
| K984136 | bard medical div | BARDEX LUBRI-SIL I.C. FOLEY CATHETER | February 16, 1999 |
| K983101 | c.r. bard | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 | November 3, 1998 |
| K971627 | rochester medical | SILICONE ANTIBACTERIAL FOLEY CATHETER | January 13, 1998 |
| K910318 | c.r. bard | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER | August 18, 1994 |