510(k) · Cleared
ClearedKARL STORZ ShuntScope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GWG Endoscope, Neurological
Cleared on May 16, 2017 as substantially equivalent to K003914 (Medtronic PS Medical, 2001) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- May 16, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002788 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK002788 Ksea Neuro-FiberscopeKARL STORZ Endoscopy-America, Inc. · 2000 · Recalled
- This deviceK170462 KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002788 | Ksea Neuro-Fiberscope | KARL STORZ Endoscopy-America, Inc. | 2000 | 4 |
| 0 (this device) | K170462 | KARL STORZ ShuntScope | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K003914 | Medtronic PS Medical Neuropen Endoscope and Optical AccessoriesSummary page 4…able for GWG product code Consensus Standards: Predicate Primary Predicate Device: Medtronic PS Medical’s NeuroPEN Endoscope Device(s): and Optical Accessories (K003914) Secondary Predicate Device: KARL STORZ Endoscopy-America’s Neuro- Fiberscope (K002788)… | 2001 |
| * | K002788 | Ksea Neuro-FiberscopeSummary page 4…N Endoscope Device(s): and Optical Accessories (K003914) Secondary Predicate Device: KARL STORZ Endoscopy-America’s Neuro- Fiberscope (K002788) Reference Device: KARL STORZ Endoscopy-America’s KSEA Sialendoscopes and Accessories (K012527) De… | 2000 |
| † | K012527 | Ksea Sialoendoscopes and Accessories | 2001 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures such as shunt placement, tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration in pediatrics and adult population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170462: KARL STORZ ShuntScope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170462
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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