K241734
- 510(k) number
- K241734
- Device name
- Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
- Applicant
- Well Lead Medical Co., Ltd. CN
- Product code
- GBM — Catheter, Urethral
- Decision date
- 2025-03-05
- Date received
- 2024-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241734.pdf
Official FDA record: K241734
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.