FDA 510(k)

Illuminated Mediastinal Access Port

K-Number: K160171 · 2016-02-26

Decision Date2016-02-26

Product CodeEWY

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Illuminated Mediastinal Access Port is the device name listed in this FDA 510(k) record. The listed applicant is Aegis Surgical, Ltd.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) 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. The listed applicant is Aegis Surgical, Ltd.. The 510(k) number is K160171.

When did Illuminated Mediastinal Access Port receive FDA 510(k) clearance?

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

Who is the listed applicant for Illuminated Mediastinal Access Port?

The FDA 510(k) record lists Aegis Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

View on FDA Database →

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