# K141622: Illuminated Mediastinoscope

- Pathway: 510(k) (Traditional)
- Applicant: Aegis Surgical, Ltd.
- Decided: Jan 9, 2015 after 206 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: 2 generations back to K954910 (1995). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K971166: Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece, Richard Wolf Medical Instruments Corp. (1997) Summary page 4.

## Most influential descendants
- K160171: Illuminated Mediastinal Access Port (2016), 1 descendant of its own
- 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/K141622
Methodology: https://510kreport.com/methodology