K233524
- 510(k) number
- K233524
- Device name
- Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)
- Applicant
- Hollister Incorporated IL · US
- Product code
- EZD — Catheter, Straight
- Decision date
- 2024-05-03
- Date received
- 2023-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233524.pdf
Official FDA record: K233524
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.