510(k) · Cleared
Recalled · Class II · 2024Aurora Surgiscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rebound Therapeutics Corporation · GWG Endoscope, Neurological
Cleared on Oct 27, 2023 as substantially equivalent to K201840 (Rebound Therapeutics, 2020) after a 59-day review. Its family tree reaches back 7 generations to 2000. 1 of the 13 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Oct 27, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- GWG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K002931 (2000). 12 ancestors in all, the oldest K830332 (1983). No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK002931 Metrx SystemMedtronic Sofamor Danek, Inc. · 2000
- 6 generations backK043602 Quadrant Retractor SystemMedtronic Sofamor Danek · 2005
- 5 generations backK060973 Vycor Surgical Access SystemsVycor Medical, LLC · 2006 · Recalled (Class I)
- 4 generations backK120691 Brain PortNico Corporation · 2012 · Recalled
- 3 generations backK182211 Aurora Surgiscope SystemRebound Therapeutics Corporation · 2019
- 2 generations backK191861 Aurora Surgiscope SystemRebound Therapeutics · 2019
- 1 generation backK201840 Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System…Rebound Therapeutics · 2020 · Recalled
- This deviceK232618 Aurora Surgiscope SystemRebound Therapeutics Corporation · 2023
Class I recalls in this family
- K060973 Vycor Surgical Access Systems5 generations back · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002931 | Metrx System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| −6 | K043602 | Quadrant Retractor System | Medtronic Sofamor Danek | 2005 | — |
| −5 | K060973 | Vycor Surgical Access Systems | Vycor Medical, LLC | 2006 | Class I |
| −4 | K120691 | Brain Port | Nico Corporation | 2012 | 2 |
| −3 | K182211 | Aurora Surgiscope System | Rebound Therapeutics Corporation | 2019 | — |
| −2 | K191861 | Aurora Surgiscope System | Rebound Therapeutics | 2019 | — |
| −1 | K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control… | Rebound Therapeutics | 2020 | 1 |
| 0 (this device) | K232618 | Aurora Surgiscope System | Rebound Therapeutics Corporation | 2023 | — |
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 |
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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2024 | Class II | Z-2331-2024 | Process change control | Potential sheath damage that could lead to tissue damage and/or track hemorrhage. |
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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K201840.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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/K232618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232618: Aurora Surgiscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232618
Report an extraction error
Are you the manufacturer?
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