K233013
- 510(k) number
- K233013
- Device name
- 2-Way 100% Silicone Cleartract Catheter
- Applicant
- Silq Technologies Corporation FL · US
- Product code
- EZL — Catheter, Retention Type, Balloon
- Decision date
- 2024-01-23
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K233013.pdf
Official FDA record: K233013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.