# K022198: Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121 & 8767.452

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Mar 21, 2003 after 259 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K973405: Yeung Endoscopic Spine System, Richard Wolf Medical Instruments Corp. (1998) Summary page 1.

## Indications for use
The MR Endoscope by Tronnier (Magnetic Resonance) allows visual observation of the operating site with simultaneous utilization of the working, supply and drain channels. The Obturator is used for atraumatic insertion of the endoscope. For examination, diagnosis and therapy in neurosurgery in conjunction with endoscopic accessories during intracranial procedures, such as: the fenestration of cysts, the removal of cysts, biopsies of lesions, coagulation of intraventricular lesions, etc. NOTE: The MR Endoscope is specially designed for use in open nuclear magnetic resonance tomographs.

Source page: https://510kreport.com/device/K022198
Methodology: https://510kreport.com/methodology