# K190719: Artemis Eye System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Aug 30, 2019 after 163 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 K002572 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002572: Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005, Medtronic PS Medical (2000) Summary page 4.

## Most influential descendants
- K201308: Axonpen, Axonmonitor, Axonbox, Tablet (2020), 1 descendant of its own
- K230125: Neuroblade System (2023), 0 descendants of its own

## Indications for use
The Artemis™ Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K190719
Methodology: https://510kreport.com/methodology