K251468
- 510(k) number
- K251468
- Device name
- Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
- Applicant
- Hollister Incorporated IL · US
- Product code
- EZD — Catheter, Straight
- Decision date
- 2025-10-03
- Date received
- 2025-05-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251468.pdf
Official FDA record: K251468
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.