510(k) · Cleared

Cleared

Olympus Endoarm

K043128510(k) TraditionalCleared Dec 21, 200439-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

Olympus Corporation · GWG Endoscope, Neurological

Cleared on Dec 21, 2004 as substantially equivalent to K971340 (Olympus Optical, Co., 1998) and 2 other predicates after a 39-day review. Its family tree reaches back 2 generations to 1993.

Decided: Dec 21, 2004
Review: 39 days
Class: Class II
Product code: GWG
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K923555 (1993). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK923555 Codman Gaab NeuroendoscopeCodman & Shurtleff, Inc. · 1993
1 generation backK971340 Olympus Neuro EndoscopeOlympus Optical, Co. · 1998
This deviceK043128 Olympus EndoarmOlympus Corporation · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K923555	Codman Gaab Neuroendoscope	Codman & Shurtleff, Inc.	1993	—
−1	K971340	Olympus Neuro Endoscope	Olympus Optical, Co.	1998	—
0 (this device)	K043128	Olympus Endoarm	Olympus Corporation	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	4	0
1998	1	0
1999	1	0

FIG. 1 — Lineage of K043128, 1993–2004Source: 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
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What was it cleared against? (3)

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
*	K971340	Olympus Neuro Endoscope Summary page 2 …vice(s) The following listed devices are the predicate medical devices; D. Model 510(k)# Manufacturer Class \| Product Code A7594A, A7T595A, A7597A \| #K971340 OLYMPUS Co,. il GWG Neuroendoscope Endoscopic system for #k982133 OLYMPUS Co,. I HRX Lumber hernia discectomy Point Setter #K…	Olympus Optical, Co.	1998	—
*	K982133	Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary Equipment Summary page 2 …ces; D. Model 510(k)# Manufacturer Class \| Product Code A7594A, A7T595A, A7597A \| #K971340 OLYMPUS Co,. il GWG Neuroendoscope Endoscopic system for #k982133 OLYMPUS Co,. I HRX Lumber hernia discectomy Point Setter #K991989 Mitaka Kohki Co,. Ltd I GWG Holder for rigid endoscope and…	The Olympus Optical Co.	1998	—
*	K991989	Mitaka Point Setter Summary page 2 …Code A7594A, A7T595A, A7597A \| #K971340 OLYMPUS Co,. il GWG Neuroendoscope Endoscopic system for #k982133 OLYMPUS Co,. I HRX Lumber hernia discectomy Point Setter #K991989 Mitaka Kohki Co,. Ltd I GWG Holder for rigid endoscope and flexible endoscope Device Description 1. Summary Subject device i…	Mitaka USA, Inc.	1999	—

Also cleared against K971340: 2 other devices →

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 11 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
None of the 8 ancestors has a recall.
2 other devices also cite its predicate K971340.

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 EndoArm system consists of the EndoAmm, a stabilizing fixation(adapter), Neuroendoscope (A1***A series). A number of components and accessories are also necessary for this system. EndoArm This product has been designed for manipulation and positioning of the Neuroendoscope during Neurosurgery and spinesurgery. Neuroendoscopes (AB1000A, AB1001A, A81002A, A81010A, AB1011A, AB1012A, AB1031A, AB1032A, AB1041A, A81042A) The Neuroendoscopes are intended…

Read the full statement (118 words)

The EndoArm system consists of the EndoAmm, a stabilizing fixation(adapter), Neuroendoscope (A1***A series). A number of components and accessories are also necessary for this system.

EndoArm

This product has been designed for manipulation and positioning of the Neuroendoscope during Neurosurgery and spinesurgery.

Neuroendoscopes (AB1000A, AB1001A, A81002A, A81010A, AB1011A, AB1012A, AB1031A, AB1032A, AB1041A, A81042A)

The Neuroendoscopes are intended for use in observation and diagnosis of the brain ventricles and brain parenchyma, such as observation and diagnosis of cerebral aneurysms, hypophysis tumors, hematomas, brain tumors, cerebral vascular systems, cranial nerve and vascular compression syndromes as well as intended for use in observation and diagnosis of the lumber and cervical spine, such as hemiated disc material, nerve roots and nucleus material.

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/K043128 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043128: Olympus Endoarm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043128

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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