Clearance Summary
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 received FDA 510(k) clearance under submission number K232067, sponsored by Medivators (A Subsidiary of Steris Corporation). The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-03-22.
- Submission: K232067
- Applicant / Sponsor: Medivators (A Subsidiary of Steris Corporation)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2024-03-22
Classification & Regulation
This clearance is catalogued under FDA product code ODC and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.