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FDA 510(k)

Illuminated Mediastinal Access Port

K-Number: K160171 · 2016-02-26

ApplicantAegis Surgical, Ltd.
Decision Date2016-02-26
Product CodeEWY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Illuminated Mediastinal Access Port is a medical device manufactured by Aegis Surgical, Ltd.. It received FDA 510(k) clearance on 2016-02-26 under approval number K160171. The device is classified under product code EWY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Illuminated Mediastinal Access Port?

Illuminated Mediastinal Access Port is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Aegis Surgical, Ltd.. The 510(k) number is K160171.

When was Illuminated Mediastinal Access Port approved by the FDA?

Illuminated Mediastinal Access Port received FDA 510(k) clearance on 2016-02-26, under approval number K160171.

What company makes Illuminated Mediastinal Access Port?

Illuminated Mediastinal Access Port is manufactured by Aegis Surgical, Ltd..

What is the FDA product code for Illuminated Mediastinal Access Port?

The FDA product code for Illuminated Mediastinal Access Port is EWY.

Related Devices (Code: EWY)

K170757Aegis Transit SystemBoston-Biomedical Associates K202272HD MediastinoscopeKarl Storz Endoscopy America, Inc. K213194HD MediastinoscopeKarl Storz Endoscopy America, Inc. K260003KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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