510(k) · Cleared

Cleared

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

K022198510(k) TraditionalCleared Mar 21, 2003259-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 Mar 21, 2003 as substantially equivalent to K970162 (Richard Wolf Medical Instruments Corp., 1997) and 1 other predicate after a 259-day review. Its family tree reaches back 2 generations to 1994.

Decided: Mar 21, 2003
Review: 259 days
Class: Class II
Product code: GWG
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K941239 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK941239 Aesculap NeuroendoscopeAesculap, Inc. · 1994
1 generation backK970162 Neurological EndoscopeRichard Wolf Medical Instruments Corp. · 1997
This deviceK022198 Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121…Richard Wolf Medical Instruments Corp. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K941239	Aesculap Neuroendoscope	Aesculap, Inc.	1994	—
−1	K970162	Neurological Endoscope	Richard Wolf Medical Instruments Corp.	1997	—
0 (this device)	K022198	Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121 & 8767.452	Richard Wolf Medical Instruments Corp.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K022198, 1994–2003Source: 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? (2)

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
*	K970162	Neurological Endoscope Summary page 1 …name: Endoscopes, rigid Endoscopes, neurological 5 10(k) Trade or proprietary or model name Manufacturer Number 1 K970162 1 Neurological Endoscope Set 1 Richard Wolf 2 K973405 2 Endoscopic Spine System 2 Ri…	Richard Wolf Medical Instruments Corp.	1997	—
*	K973405	Yeung Endoscopic Spine System Summary page 1 …5 10(k) Trade or proprietary or model name Manufacturer Number 1 K970162 1 Neurological Endoscope Set 1 Richard Wolf 2 K973405 2 Endoscopic Spine System 2 Richard Wolf 1.O Description The submitted endoscope set is equivale…	Richard Wolf Medical Instruments Corp.	1998	—

Also cleared against K970162: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K970162.

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 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022198 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022198: Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121 & 8767.452.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022198

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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