DCX Disposable Cassette (DCX)— 510(k) K243998

Name: FDA 510(k) clearance K243998
Creator: U.S. Food and Drug Administration
Published: 2025-04-25

Substantially Equivalent

Institut Geroges Lopez

FDA 510(k) clearance K243998 for DCX Disposable Cassette (DCX), Substantially Equivalent on 2025-04-25. Applicant: Institut Geroges Lopez. Device class: 2.

Clearance details

Applicant: Institut Geroges Lopez
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2024-12-26
Decision date: 2025-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lissieu, FR

Download summary PDF View on FDA.gov ↗

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