K232329
- 510(k) number
- K232329
- Device name
- Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
- Applicant
- Medivators (A Subsidiary of Steris Corporation) TX · US
- Product code
- ODC — Endoscope Channel Accessory
- Decision date
- 2023-12-21
- Date received
- 2023-08-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K232329.pdf
Official FDA record: K232329
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.