FMX314 Surgical Platform— 510(k) K160797

Name: FDA 510(k) clearance K160797
Creator: U.S. Food and Drug Administration
Published: 2016-08-26

Substantially Equivalent

Fortimedix Surgical B.V.

FDA 510(k) clearance K160797 for FMX314 Surgical Platform, Substantially Equivalent on 2016-08-26. Applicant: Fortimedix Surgical B.V.. Device class: 2.

Clearance details

Applicant: Fortimedix Surgical B.V.
Product code: Code OTJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2016-03-23
Decision date: 2016-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nuth, NL

Download summary PDF View on FDA.gov ↗

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