K243433
- 510(k) number
- K243433
- Device name
- enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
- Applicant
- STERIS Corporation OH · US
- Product code
- FEB — Accessories, Cleaning, For Endoscope
- Decision date
- 2024-12-02
- Date received
- 2024-11-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K243433.pdf
Official FDA record: K243433
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.