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— 510(k) K232067

Name: FDA 510(k) clearance K232067
Creator: U.S. Food and Drug Administration
Published: 2024-03-22

Substantially Equivalent

Medivators (A Subsidiary of Steris Corporation)

FDA 510(k) clearance K232067 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, Substantially Equivalent on 2024-03-22. Applicant: Medivators (A Subsidiary of Steris Corporation). Device class: 2.

Clearance details

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: 2023-07-11
Decision date: 2024-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODC

view all

K252933 — DYNE PORT2026-06-12
K250145 — Biopsy Port Adapter2025-10-17
K252910 — Orca Air/Water and Suction Valves2025-10-09
K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)2025-07-16
K250732 — Disposable Endoscopy Valve Set2025-06-20

More clearances from Medivators (A Subsidiary of Steris Corporation)

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.