# K192523: CMOS Video Esophagoscope SSU

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Jan 24, 2020 after 133 days
- Product code: EOX (Esophagoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921244 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051972: Karl Storz Trans-Nasal Esophagoscope, KARL STORZ Endoscopy-America, Inc. (2005) Summary page 4.

## Indications for use
The CMOS Video Esophagoscope SSU is intended to provide visualization of nasal sinuses, larynx, esophagus and gastroesophageal junction during diagnostic procedures. The E-Box serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

Source page: https://510kreport.com/device/K192523
Methodology: https://510kreport.com/methodology