Wellead® Latex Foley Catheter— 510(k) K233094
Substantially EquivalentWell Lead Medical (Hainan) Co., Ltd.
FDA 510(k) clearance K233094 for Wellead® Latex Foley Catheter, Substantially Equivalent on 2024-06-06. Applicant: Well Lead Medical (Hainan) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Well Lead Medical (Hainan) Co., Ltd.
- Product code
- Code MJC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Haikou, CN
Recent devices under product code MJC
view all- 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
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.