K242049
- 510(k) number
- K242049
- Device name
- SureCath Set
- Applicant
- Coloplast Corp. MN · US
- Product code
- EZD — Catheter, Straight
- Decision date
- 2024-11-26
- Date received
- 2024-07-12
- 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: K242049.pdf
Official FDA record: K242049
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.