510(k) · Cleared
ClearedAurora Evacuator +Coag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rebound Therapeutics · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 12, 2020 as substantially equivalent to K960455 (Kirwan Surgical Products, Inc., 1996) after a 57-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Aug 12, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960455 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK960455 Bipolar Suction CoagulatorKirwan Surgical Products, Inc. · 1996
- This deviceK201637 Aurora Evacuator +CoagRebound Therapeutics · 2020
- Descendant · cites it directly · 1 of its ownK203745 AURORA Evacuator +CoagRebound Therapeutics · 2021
- Descendant · 2 generations on · 0 of its ownK230125 Neuroblade SystemClearmind Biomedical · 2023
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 |
|---|---|---|---|---|---|
| −1 | K960455 | Bipolar Suction Coagulator | Kirwan Surgical Products, Inc. | 1996 | — |
| 0 (this device) | K201637 | Aurora Evacuator +Coag | Rebound Therapeutics | 2020 | — |
| +1 | K203745 | AURORA Evacuator +Coag | Rebound Therapeutics | 2021 | — |
| +2 | K230125 | Neuroblade System | Clearmind Biomedical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K960455 | Bipolar Suction CoagulatorSummary page 4…tion Name: Electrosurgical Cutting & Coagulation Device & Accessories Regulatory Class: II Product Code: GEI PREDICATE DEVICE Primary: K960455, Bipolar Suction Coagulator, Kirwan Surgical Products Reference: K190075/K180372, AURORA Evacuator, Rebound Therapeutics D… | 1996 |
| † | K190075 | Aurora Evacuator | 2019 |
| † | K180372 | Aurora Evacuator | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203745 | AURORA Evacuator +Coag | 2021 | 1 |
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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201637: Aurora Evacuator +Coag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201637
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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