K232004
- 510(k) number
- K232004
- Device name
- Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
- Applicant
- Medivators (A Subsidiary of Steris Corporation) TX · US
- Product code
- ODC — Endoscope Channel Accessory
- Decision date
- 2024-03-06
- Date received
- 2023-07-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K232004.pdf
Official FDA record: K232004
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.