Illuminated Mediastinal Access Port— 510(k) K160171

Name: FDA 510(k) clearance K160171
Creator: U.S. Food and Drug Administration
Published: 2016-02-26

Substantially Equivalent

Aegis Surgical, Ltd.

FDA 510(k) clearance K160171 for Illuminated Mediastinal Access Port, Substantially Equivalent on 2016-02-26. Applicant: Aegis Surgical, Ltd.. Device class: 2.

Clearance details

Applicant: Aegis Surgical, Ltd.
Product code: Code EWY
Device class: Class 2
Regulation: 21 CFR 874.4720
Advisory panel: Ear, Nose, Throat
Date received: 2016-01-27
Decision date: 2016-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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