# K031858: Neuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths, Working Elements, Bipolar and Unipolar Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Jul 29, 2004 after 409 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 K941239 (1994). 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)
- K970162: Neurological Endoscope, Richard Wolf Medical Instruments Corp. (1997) Summary page 1.

## Indications for use
The Minature Neuro-Endoscope System by Hopf allows visual observation of the operating site while using working channels, supply and drain channels. They are used for diagnosis and therapy in neurosurgery, in connection with endoscopic accessories, during intracranial procedures. The EANS System (Endoscopic Assisted Neuro Surgery) allows a visualization of cerebral structures not visible through the microscope and at the same time offers the option of supplying and draining irrigation fluid, for examination and diagnosis of microsurgical brain operation.

Source page: https://510kreport.com/device/K031858
Methodology: https://510kreport.com/methodology