K233094
- 510(k) number
- K233094
- Device name
- Wellead® Latex Foley Catheter
- Applicant
- Well Lead Medical (Hainan) Co., Ltd. CN
- Product code
- MJC — Catheter, Urological (Antimicrobial) And Accessories
- Decision date
- 2024-06-06
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233094.pdf
Official FDA record: K233094
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.