Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm
Summary
Medivators (A Subsidiary of Steris Corporation) received 510(k) clearance for 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, a ODC device. Cleared on 2024-03-22.
Details
Source
510(k) Clearance
External ID
K232067
Action Date
2024-03-22
Status
Traditional
Category
device
Product Code
ODC
Product Description
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. Product code: ODC.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Medivators (A Subsidiary of Steris Corporation) has received 3 total clearances in our database.
Medivators (A Subsidiary of Steris Corporation) has 3 FDA actions in our database, including 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Medivators (A Subsidiary of Steris Corporation) have FDA actions?
Medivators (A Subsidiary of Steris Corporation) has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232067" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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