K232067
- 510(k) number
- K232067
- Device name
- Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector
- Applicant
- Medivators (A Subsidiary of Steris Corporation) TX · US
- Product code
- ODC — Endoscope Channel Accessory
- Decision date
- 2024-03-22
- Date received
- 2023-07-11
- 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: K232067.pdf
Official FDA record: K232067
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.