# K170757: Aegis Transit System

- Pathway: 510(k) (Traditional)
- Applicant: Boston-Biomedical Associates
- Decided: Jul 14, 2017 after 123 days
- Product code: EWY (Mediastinoscope, Surgical)
- Device class: 2
- Regulation: 21 CFR 874.4720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954910 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141622: Illuminated Mediastinoscope, Aegis Surgical, Ltd. (2015) Summary page 4.
- K160171: Illuminated Mediastinal Access Port, Aegis Surgical, Ltd. (2016) Summary page 4.

## Indications for use
The Aegis Transit System is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures (e.g., lung, tracheal and esophageal procedures, access to aorta for transcatheter valve procedures and/or thoracic endovascular aortic repair). The Aegis Transit System is specifically indicated for use in the anterior, superior and middle mediastinum.

Source page: https://510kreport.com/device/K170757
Methodology: https://510kreport.com/methodology