510(k) · Cleared
ClearedMedtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic PS Medical · GWG Endoscope, Neurological
Cleared on Nov 16, 2000 after a 90-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
- Nov 16, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK002572 Medtronic PS Medical Channelscope Endoscope, Models 2232-001…Medtronic PS Medical · 2000
- Descendant · cites it directly · 2 of its ownK190719 Artemis Eye SystemPenumbra, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK201308 Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020
- Descendant · 3 generations on · 0 of its ownK230125 Neuroblade SystemClearmind Biomedical · 2023
- Descendant · cites it directly · 0 of its ownK014149 Paediscope, Model # P010A and PF011AAesculap, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K190719Artemis Eye SystemPenumbra, Inc. · 2019 · cites it directly2descendants
- K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020 · 2 generations on1descendant
- K230125Neuroblade SystemClearmind Biomedical · 2023 · 3 generations on0descendants
- K014149Paediscope, Model # P010A and PF011AAesculap, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002572 | Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002… | Medtronic PS Medical | 2000 | — |
| +1 | K190719 | Artemis Eye System | Penumbra, Inc. | 2019 | — |
| +2 | K201308 | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | 2020 | — |
| +3 | K230125 | Neuroblade System | Clearmind Biomedical | 2023 | — |
| +1 | K014149 | Paediscope, Model # P010A and PF011A | Aesculap, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 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? (4)
2 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?
- Of its descendants, K190719 (Penumbra, Inc., 2019) has gone furthest, with 2 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/K002572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002572: Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002572
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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