# K970162: Neurological Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Oct 29, 1997 after 286 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 K941239 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K941239: Aesculap Neuroendoscope, Aesculap, Inc. (1994) Summary page 1.
- (no number) Gaab Neuroendoscope system Sheath, 83-1521: named in the summary without a submission number
- (no number) Auero Neuroendoscope system Sheath 28160D: named in the summary without a submission number
- (no number) Sheath Insert W/ Inflow Stopcock Connection 28160J: named in the summary without a submission number
- (no number) Bougie Guide Obturator: named in the summary without a submission number
- (no number) Telescope Gaab 83-1523: named in the summary without a submission number
- (no number) Auero system Telescope 27020A: named in the summary without a submission number
- (no number) Auero Monopolar coagulating Electrode 27160B: named in the summary without a submission number
- (no number) Injection Needle 83-1534: named in the summary without a submission number
- (no number) Suction Catheter 10468A: named in the summary without a submission number

## Most influential descendants
- K031858: Neuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths, Working Elements, Bipolar and Unipolar Electrodes (2004), 0 descendants of its own
- K022198: Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121 & 8767.452 (2003), 0 descendants of its own

## Indications for use
The device is intended for use for direct visualization, diagnosis and therapeutic application during intracranial procedures, such as cyst fenestration shunt placement ventriculostomy of the 3rd ventricle when the aqueduct is obstructed intraventricular coagulation coagulation of small intraventricular lesions biopsy of lesions which lead to the stricture of a ventricle The instrument simultaneously permits visual control and utilization of a working, an irrigation, and an aspiration channel. The Neuro-Endoscope can be used with or without a stereotactic frame. A special adapter is available to affix the endoscope.

Source page: https://510kreport.com/device/K970162
Methodology: https://510kreport.com/methodology