510(k) · Cleared
ClearedCodman Gaab Neuroendoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · GWB Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
Cleared on Mar 23, 1993 after a 249-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 23, 1993
- Review
- 249 days
- Class
- Class I
- Product code
- GWB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK923555 Codman Gaab NeuroendoscopeCodman & Shurtleff, Inc. · 1993
- Descendant · cites it directly · 3 of its ownK971340 Olympus Neuro EndoscopeOlympus Optical, Co. · 1998
- Descendant · 2 generations on · 0 of its ownK043128 Olympus EndoarmOlympus Corporation · 2004
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK013759 MSS-28CS-301/701 NeedlescopeOlympus Optical Co., Ltd. · 2002
Most influential descendants
Showing 4 of 4 · See all- K971340Olympus Neuro EndoscopeOlympus Optical, Co. · 1998 · cites it directly3descendants
- K043128Olympus EndoarmOlympus Corporation · 2004 · 2 generations on0descendants
- K020507Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4Olympus Winter & Ibe GmbH · 2002 · 2 generations on0descendants
- K013759MSS-28CS-301/701 NeedlescopeOlympus Optical Co., Ltd. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923555 | Codman Gaab Neuroendoscope | Codman & Shurtleff, Inc. | 1993 | — |
| +1 | K971340 | Olympus Neuro Endoscope | Olympus Optical, Co. | 1998 | — |
| +2 | K043128 | Olympus Endoarm | Olympus Corporation | 2004 | — |
| +2 | K020507 | Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4 | Olympus Winter & Ibe GmbH | 2002 | — |
| +2 | K013759 | MSS-28CS-301/701 Needlescope | Olympus Optical Co., Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971340 | Olympus Neuro Endoscope | 1998 | 3 |
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?
- Of its descendants, K971340 (Olympus Optical, Co., 1998) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GWB devicesGWB Antisera, Fluorescent, All Types, Streptococcus Pneumoniae: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWB
FDA has decided no GWB device since 2007.
Median 510(k) review, days · GWB
Too few GWB 510(k)s in any year since 2007 to give a median.
Recalls per year · GWB
No recall names GWB since 2007.
Adverse event reports per year · GWB
No MAUDE report names GWB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K923555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923555: Codman Gaab Neuroendoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923555
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026