# K213194: HD Mediastinoscope

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Jun 23, 2022 after 267 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: 1 generation back to K954910 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954910: Karl Storz Optical Mediastinoscope, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 4.

## Most influential descendants
- K260003: KARL STORZ Mediastinoscopes and Instruments (2026), 0 descendants of its own

## Indications for use
The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.

Source page: https://510kreport.com/device/K213194
Methodology: https://510kreport.com/methodology