Defendo Fujifilm 700 Single Use Cleaning Adapter— 510(k) K250140

Name: FDA 510(k) clearance K250140
Creator: U.S. Food and Drug Administration
Published: 2025-02-20

Substantially Equivalent

Steris Corparation

FDA 510(k) clearance K250140 for Defendo Fujifilm 700 Single Use Cleaning Adapter, Substantially Equivalent on 2025-02-20. Applicant: Steris Corparation. Device class: 2.

Clearance details

Applicant: Steris Corparation
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-01-17
Decision date: 2025-02-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, 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 Steris Corparation

view all

K213412 — VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM2022-01-21

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