MJC
- Product code
- MJC
- Device name
- Catheter, Urological (Antimicrobial) And Accessories
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5130
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 10 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233094 | 2024-06-06 | Well Lead Medical (Hainan) Co., Ltd. | Wellead® Latex Foley Catheter |
Official FDA classification page: MJC
Classification and pathway per current FDA publications. Data from openFDA (CC0).