# K160171: Illuminated Mediastinal Access Port

- Pathway: 510(k) (Special)
- Applicant: Aegis Surgical, Ltd.
- Decided: Feb 26, 2016 after 30 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: 3 generations back to K954910 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K170757: Aegis Transit System (2017), 0 descendants of its own

## Indications for use
The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures. The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.

Source page: https://510kreport.com/device/K160171
Methodology: https://510kreport.com/methodology