K233411
- 510(k) number
- K233411
- Device name
- Folysil Silicone Catheter
- Applicant
- Coloplast Corp. MN · US
- Product code
- EZL — Catheter, Retention Type, Balloon
- Decision date
- 2024-04-15
- Date received
- 2023-10-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233411.pdf
Official FDA record: K233411
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.