510(k) · Cleared
Recalled · Class II · 2025Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rebound Therapeutics · GWG Endoscope, Neurological
Cleared on Nov 4, 2020 as substantially equivalent to K191861 (Rebound Therapeutics, 2019) after a 125-day review. Its family tree reaches back 6 generations to 2000. 1 of the 14 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 4, 2020
- Review
- 125 days
- Class
- Class II
- Product code
- GWG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002931 (2000). 11 ancestors in all, the oldest K830332 (1983). 2 later devices descend from it, 2 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK002931 Metrx SystemMedtronic Sofamor Danek, Inc. · 2000
- 5 generations backK043602 Quadrant Retractor SystemMedtronic Sofamor Danek · 2005
- 4 generations backK060973 Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · Recalled (Class I)
- 3 generations backK120691 Brain PortNico Corporation · 2012 · Recalled
- 2 generations backK182211 Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019
- 1 generation backK191861 Aurora Surgiscope SystemRebound Therapeutics · 2019
- This deviceK201840 Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System…Rebound Therapeutics · 2020
- Descendant · cites it directly · 0 of its ownK250752 AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System…Integra LifeSciences Corporation · 2025
- Descendant · cites it directly · 0 of its ownK232618 Aurora Surgiscope SystemRebound Therapeutics Corporation · 2023 · Recalled
Class I recalls in this family
- K060973 Vycor Surgical Access Systems4 generations back · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002931 | Metrx System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| −5 | K043602 | Quadrant Retractor System | Medtronic Sofamor Danek | 2005 | — |
| −4 | K060973 | Vycor Surgical Access Systems | Vycor Medical, LLC | 2006 | Class I |
| −3 | K120691 | Brain Port | Nico Corporation | 2012 | 2 |
| −2 | K182211 | Aurora Surgiscope System | Rebound Therapeutics Corporation | 2019 | — |
| −1 | K191861 | Aurora Surgiscope System | Rebound Therapeutics | 2019 | — |
| 0 (this device) | K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control… | Rebound Therapeutics | 2020 | — |
| +1 | K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Integra LifeSciences Corporation | 2025 | — |
| +1 | K232618 | Aurora Surgiscope System | Rebound Therapeutics Corporation | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 2 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K191861 | Aurora Surgiscope SystemSummary page 4…Self-retaining retractor for neurosurgery Regulatory Class: II Product Code: GWG, GZT PREDICATE DEVICE AURORA Surgiscope System, Rebound Therapeutics, K191861 NICO BrainPath, NICO Corp, K172433 (Reference device) DEVICE DESCRIPTION The Aurora Surgiscope System consists of two components:… | 2019 |
| † | K172433 | NICO BrainPath | 2017 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2025 | Class II | Z-1295-2025 | Process control | Possibility for the obturator to break (separate). |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060973Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K250752 (Integra LifeSciences Corporation, 2025) 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. 2020, 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 AURORA Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201840: Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201840
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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