510(k) · Cleared
ClearedOlympus Neuro Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical, Co. · GWG Endoscope, Neurological
Cleared on Jul 29, 1998 as substantially equivalent to K923555 (Codman & Shurtleff, Inc., 1993) after a 475-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Jul 29, 1998
- Review
- 475 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923555 (1993). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK923555 Codman Gaab NeuroendoscopeCodman & Shurtleff, Inc. · 1993
- This deviceK971340 Olympus Neuro EndoscopeOlympus Optical, Co. · 1998
- Descendant · cites it directly · 0 of its ownK043128 Olympus EndoarmOlympus Corporation · 2004
- Descendant · cites it directly · 0 of its ownK020507 Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4Olympus Winter & Ibe GmbH · 2002
- Descendant · cites it directly · 0 of its ownK013759 MSS-28CS-301/701 NeedlescopeOlympus Optical Co., Ltd. · 2002
Most influential descendants
Showing 3 of 3 · See all- K043128Olympus EndoarmOlympus Corporation · 2004 · cites it directly0descendants
- K020507Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4Olympus Winter & Ibe GmbH · 2002 · cites it directly0descendants
- K013759MSS-28CS-301/701 NeedlescopeOlympus Optical Co., Ltd. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923555 | Codman Gaab Neuroendoscope | Codman & Shurtleff, Inc. | 1993 | — |
| 0 (this device) | K971340 | Olympus Neuro Endoscope | Olympus Optical, Co. | 1998 | — |
| +1 | K043128 | Olympus Endoarm | Olympus Corporation | 2004 | — |
| +1 | K020507 | Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4 | Olympus Winter & Ibe GmbH | 2002 | — |
| +1 | K013759 | MSS-28CS-301/701 Needlescope | Olympus Optical Co., Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K923555 | Codman Gaab NeuroendoscopeSummary page 2…icate Devices: The intended use of the Olympus Neuro Endoscope is similar to the currently marketed Codman Neuro Endoscope which was cleared for marketing under 510(k) #K923555. Both endoscopes are similar in intended use, design and construction. lows: Testing has been performed in accordance with FDA’… | 1993 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K043128 (Olympus Corporation, 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 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 Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.
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/K971340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971340: Olympus Neuro Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971340
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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