ENDOFIX EXO— 510(k) K232405

Substantially Equivalent

Aktormed GmbH

FDA 510(k) clearance K232405 for ENDOFIX EXO, Substantially Equivalent on 2024-04-25. Applicant: Aktormed GmbH. Device class: 2.

Clearance details

Applicant: Aktormed GmbH
Product code: Code OCV
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-08-10
Decision date: 2024-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neutraubling, DE

Download summary PDF View on FDA.gov ↗

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