FDA 510(k)

Aegis Transit System

K-Number: K170757 · 2017-07-14

Decision Date2017-07-14

Product CodeEWY

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Aegis Transit System is the device name listed in this FDA 510(k) record. The listed applicant is Boston-Biomedical Associates. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K170757. 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 Aegis Transit System?

Aegis Transit System is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Boston-Biomedical Associates. The 510(k) number is K170757.

When did Aegis Transit System receive FDA 510(k) clearance?

Aegis Transit System received FDA 510(k) clearance on 2017-07-14, under 510(k) number K170757.

Who is the listed applicant for Aegis Transit System?

The FDA 510(k) record lists Boston-Biomedical Associates as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aegis Transit System?

The FDA product code for Aegis Transit System 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.K160171Illuminated Mediastinal Access PortAegis Surgical, Ltd.

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.