# K020507: Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Oct 8, 2002 after 235 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: 2 generations back to K923555 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971340: Olympus Neuro Endoscope, Olympus Optical, Co. (1998)

## Indications for use
The Olympus Neuroendoscopes are intended for viewing the ventricles of the brain, for use in endoscopic assisted microsurgery for cerebral aneurysms, and shunt placement and for visualization of tumors, cysts and neurovascular compression syndromes.

Source page: https://510kreport.com/device/K020507
Methodology: https://510kreport.com/methodology