K232914
- 510(k) number
- K232914
- Device name
- SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
- Applicant
- STERIS Corporation OH · US
- Product code
- MED — Sterilant, Medical Devices
- Decision date
- 2023-10-03
- Date received
- 2023-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K232914.pdf
Official FDA record: K232914
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.