510(k) · Cleared

Cleared

Neurological Endoscope

K970162510(k) TraditionalCleared Oct 29, 1997286-day reviewClass II21 CFR 882.1480

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Richard Wolf Medical Instruments Corp. · GWG Endoscope, Neurological

Cleared on Oct 29, 1997 as substantially equivalent to K941239 (Aesculap, Inc., 1994) after a 286-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.

Decided: Oct 29, 1997
Review: 286 days
Class: Class II
Product code: GWG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K941239 (1994). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK941239 Aesculap NeuroendoscopeAesculap, Inc. · 1994
This deviceK970162 Neurological EndoscopeRichard Wolf Medical Instruments Corp. · 1997
Descendant · cites it directly · 0 of its ownK031858 Neuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths…Richard Wolf Medical Instruments Corp. · 2004
Descendant · cites it directly · 0 of its ownK022198 Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121…Richard Wolf Medical Instruments Corp. · 2003

Most influential descendants

Showing 2 of 2 · See all

K031858Neuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths, Working Elements…Richard Wolf Medical Instruments Corp. · 2004 · cites it directly0descendants
K022198Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121 & 8767.452Richard Wolf Medical Instruments Corp. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941239	Aesculap Neuroendoscope	Aesculap, Inc.	1994	—
0 (this device)	K970162	Neurological Endoscope	Richard Wolf Medical Instruments Corp.	1997	—
+1	K031858	Neuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths, Working…	Richard Wolf Medical Instruments Corp.	2004	—
+1	K022198	Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121 & 8767.452	Richard Wolf Medical Instruments Corp.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0

FIG. 1 — Lineage of K970162, 1994–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GWG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GWG device

#1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (10)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K941239	Aesculap Neuroendoscope Summary page 1 …7 Aucro Monoplar coagulating Electrode 27160B 7 Storz 8 8 Injection Needle 83-1534 8 Codman 9 9 Suction Catheter 10468 A 9 Storz (10 10 Neuroendoscope (Ventriculoscope) K941239 10 Asculap 1.0 Description The set consists of a sheath, obturators, telescope, forceps, scissors, electrodes, suction needle, a…	Aesculap, Inc.	1994	—
*	—	Gaab Neuroendoscope system Sheath, 83-1521 Named without a submission number			—
*	—	Auero Neuroendoscope system Sheath 28160D Named without a submission number			—
*	—	Sheath Insert W/ Inflow Stopcock Connection 28160J Named without a submission number			—
*	—	Bougie Guide Obturator Named without a submission number			—
*	—	Telescope Gaab 83-1523 Named without a submission number			—
*	—	Auero system Telescope 27020A Named without a submission number			—
*	—	Auero Monopolar coagulating Electrode 27160B Named without a submission number			—
*	—	Injection Needle 83-1534 Named without a submission number			—
*	—	Suction Catheter 10468A Named without a submission number			—

Also cleared against K941239: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031858	Neuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths, Working Elements…	Richard Wolf Medical Instruments Corp.	2004	0
K022198	Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121 & 8767.452	Richard Wolf Medical Instruments Corp.	2003	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K031858 (Richard Wolf Medical Instruments Corp., 2004) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K941239.

How does its category compare?

All GWG devices

GWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWG

2in 2025

2007high 5 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWG

269in 2023

2007high 269 (2023) · low 106 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWG

2in 2011

2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWG

33in 2025

2007high 37 (2015) · low 0 (2009)2025

MAUDE reports naming product code GWG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	3
2008	2	—	0	5
2009	0	—	1	0
2010	0	—	0	1
2011	0	—	2	4
2012	0	—	0	7
2013	1	—	0	3
2014	2	—	0	19
2015	0	—	0	37
2016	2	—	0	25
2017	4	126	0	12
2018	4	128	0	16
2019	3	156	0	10
2020	2	—	0	19
2021	3	106	0	21
2022	0	—	0	12
2023	5	269	0	9
2024	1	—	0	9
2025	2	—	0	33
2026	4	217	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970162 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970162: Neurological Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970162

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026