K232918
- 510(k) number
- K232918
- Device name
- enspire 300 Series Automated Endoscope Reprocessor
- Applicant
- STERIS Corporation OH · US
- Product code
- NZA — Accessories, Germicide, Cleaning, For Endoscopes
- Decision date
- 2023-10-03
- Date received
- 2023-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232918.pdf
Official FDA record: K232918
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.