# K232159: QEVO System

- Pathway: 510(k) (Special)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Sep 21, 2023 after 63 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- 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 K170667 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170667: QEVO System with KINEVO 900, Carl Zeiss Meditec, AG (2017) Summary page 5.

## Indications for use
The QEVO System is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.

Source page: https://510kreport.com/device/K232159
Methodology: https://510kreport.com/methodology