K253295
- 510(k) number
- K253295
- Device name
- Coude Sleeved IC; Coude Plus Sleeved IC
- Applicant
- Hollister Incorporated IL · US
- Product code
- EZD — Catheter, Straight
- Decision date
- 2026-05-18
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253295.pdf
Official FDA record: K253295
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.