K241424
- 510(k) number
- K241424
- Device name
- InnoCare Specialty Foley Catheter
- Applicant
- Innocare Urologics, LLC FL · US
- Product code
- EZL — Catheter, Retention Type, Balloon
- Decision date
- 2024-09-18
- Date received
- 2024-05-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K241424.pdf
Official FDA record: K241424
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.