ILLUMINATED MEDIASTINOSCOPE— 510(k) K141622

Name: FDA 510(k) clearance K141622
Creator: U.S. Food and Drug Administration
Published: 2015-01-09

Substantially Equivalent

Aegis Surgical, Ltd.

FDA 510(k) clearance K141622 for ILLUMINATED MEDIASTINOSCOPE, Substantially Equivalent on 2015-01-09. 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: 2014-06-17
Decision date: 2015-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holly Springs, NC, US

Download summary PDF View on FDA.gov ↗

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