510(k) · Cleared
ClearedBipolar Suction Coagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kirwan Surgical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 27, 1996 after a 28-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Feb 27, 1996
- Review
- 28 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK960455 Bipolar Suction CoagulatorKirwan Surgical Products, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK965241 Bipolar Suction CoagulatorKirwan Surgical Products, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK201637 Aurora Evacuator +CoagRebound Therapeutics · 2020
- Descendant · cites it directly · 1 of its ownK203745 AURORA Evacuator +CoagRebound Therapeutics · 2021
- Descendant · cites it directly · 1 of its ownK150993 NICO TRIOwandNico Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK993009 Hydrocision Arthrojet System with CauteryHydrocision, Inc. · 1999
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K965241Bipolar Suction CoagulatorKirwan Surgical Products, Inc. · 1997 · cites it directly3descendants
- K201637Aurora Evacuator +CoagRebound Therapeutics · 2020 · cites it directly2descendants
- K203745AURORA Evacuator +CoagRebound Therapeutics · 2021 · cites it directly1descendant
- K150993NICO TRIOwandNico Corporation · 2015 · cites it directly1descendant
- K993009Hydrocision Arthrojet System with CauteryHydrocision, Inc. · 1999 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960455 | Bipolar Suction Coagulator | Kirwan Surgical Products, Inc. | 1996 | — |
| +1 | K965241 | Bipolar Suction Coagulator | Kirwan Surgical Products, Inc. | 1997 | — |
| +1 | K201637 | Aurora Evacuator +Coag | Rebound Therapeutics | 2020 | — |
| +1 | K203745 | AURORA Evacuator +Coag | Rebound Therapeutics | 2021 | — |
| +1 | K150993 | NICO TRIOwand | Nico Corporation | 2015 | — |
| +2 | K993009 | Hydrocision Arthrojet System with Cautery | Hydrocision, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
4 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, K965241 (Kirwan Surgical Products, Inc., 1997) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K960455 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960455: Bipolar Suction Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960455
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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