Defendo Fujifilm 700 Single Use Biopsy Valve +4 more— 510(k) K232329

Substantially Equivalent

Medivators (A Subsidiary of Steris Corporation)

FDA 510(k) clearance K232329 for Defendo Fujifilm 700 Single Use Biopsy Valve +4 more, Substantially Equivalent on 2023-12-21. Applicant: Medivators (A Subsidiary of Steris Corporation). Device class: 2.

Clearance details

Device name as filed
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)
Product code
Code ODC
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Conroe, TX, US
Download summary PDFView on FDA.gov ↗

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