510(k) · Cleared
ClearedCodman (R) Ridig and Steerable Endoscope Holder, Model 83-1352
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · GWG Endoscope, Neurological
Cleared on Feb 3, 1995 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Feb 3, 1995
- Review
- 81 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK945572 Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352Johnson & Johnson Professionals, Inc. · 1995
- Descendant · cites it directly · 10 of its ownK992006 Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999
- Descendant · 2 generations on · 9 of its ownK050051 Armand Endoscope HolderKLS-Martin L.P. · 2005
- Descendant · 2 generations on · 4 of its ownK070509 Fisso Holding SystemBaitella AG · 2007
- Descendant · 3 generations on · 2 of its ownK190576 WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
- Descendant · 3 generations on · 2 of its ownK061292 Statarius, Model 001 003Kinetic Surgical, LLC · 2006
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K992006Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999 · cites it directly10descendants
- K050051Armand Endoscope HolderKLS-Martin L.P. · 2005 · 2 generations on9descendants
- K070509Fisso Holding SystemBaitella AG · 2007 · 2 generations on4descendants
- K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019 · 3 generations on2descendants
- K061292Statarius, Model 001 003Kinetic Surgical, LLC · 2006 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945572 | Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352 | Johnson & Johnson Professionals, Inc. | 1995 | — |
| +1 | K992006 | Neuroview Instrument Holder, Model 300-33 | Integra Neurocare, LLC | 1999 | — |
| +2 | K050051 | Armand Endoscope Holder | KLS-Martin L.P. | 2005 | — |
| +2 | K070509 | Fisso Holding System | Baitella AG | 2007 | — |
| +3 | K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | 2019 | — |
| +3 | K061292 | Statarius, Model 001 003 | Kinetic Surgical, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992006 | Neuroview Instrument Holder, Model 300-33 | 1999 | 10 |
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, K992006 (Integra Neurocare, LLC, 1999) has gone furthest, with 10 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 | — |
https://510kreport.com/device/K945572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945572: Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945572
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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