K253267
- 510(k) number
- K253267
- Device name
- CORIS System
- Applicant
- Nanosonics Limited AU
- Product code
- SEW — Automated Endoscope Channel Cleaner
- Decision date
- 2026-03-05
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253267.pdf
Official FDA record: K253267
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.