510(k) · Cleared
Recalled · Class II · 2021Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bovie Medical Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 29, 2016 as substantially equivalent to K120791 (Arthocare Corporation, 2012) and 2 other predicates after a 53-day review. Its family tree reaches back 15 generations to 2001. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 29, 2016
- Review
- 53 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 15 generations to K011083 (2001). 80 ancestors in all, the oldest K852143 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 11 generations between
- 3 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 2 generations backK120791 Ambient Turboflash 90 IfsArthocare Corporation · 2012
- 1 generation backK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
- This deviceK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016
- Descendant · cites it directly · 1 of its ownK231126 Eblator DeviceE Surgical, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK251899 E BlatorNew Deantronics Taiwan, Ltd. · 2025
Show all 15 generations
- Root · 15 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 14 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 13 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 12 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 11 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 10 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 9 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 8 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 7 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 6 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 5 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 4 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 3 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 2 generations backK120791 Ambient Turboflash 90 IfsArthocare Corporation · 2012
- 1 generation backK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
- This deviceK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016
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 |
|---|---|---|---|---|---|
| −15 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −14 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −13 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −12 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −11 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −10 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −9 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −8 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −7 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −6 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −5 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −4 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| −3 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| −2 | K120791 | Ambient Turboflash 90 Ifs | Arthocare Corporation | 2012 | — |
| −1 | K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016 | 2 |
| 0 (this device) | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating… | Bovie Medical Corporation | 2016 | — |
| +1 | K231126 | Eblator Device | E Surgical, LLC | 2023 | — |
| +2 | K251899 | E Blator | New Deantronics Taiwan, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K120791 | Ambient Turboflash 90 IfsSummary page 5…Page 2 of 7 Classification: 21CFR 878.4400; Class II; Product Code GEI Legally Marketed Predicate Device(s): • K120791, K083306 ArthroCare SuperTurbo Vac 90, TurboVac 90, Arthrocare ArthroWand® 2.3mm 35° Short Bevel and Microblator 30 With… | 2012 |
| * | K083306 | Modification to Arthrocare ArthrowandsSummary page 5…Page 2 of 7 Classification: 21CFR 878.4400; Class II; Product Code GEI Legally Marketed Predicate Device(s): • K120791, K083306 ArthroCare SuperTurbo Vac 90, TurboVac 90, Arthrocare ArthroWand® 2.3mm 35° Short Bevel and Microblator 30 With Integrate… | 2008 |
| * | K152777 | Bovie Disposable Bipolar AblatorSummary page 5…• K120791, K083306 ArthroCare SuperTurbo Vac 90, TurboVac 90, Arthrocare ArthroWand® 2.3mm 35° Short Bevel and Microblator 30 With Integrated Cable • K152777 Bovie Disposable Bipolar Ablator INTENDED USE/INDICATIONS This device is intended to be used for cutting, vaporization, and coa… | 2016 |
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 |
|---|---|---|---|
| K231126 | Eblator Device | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2021 | Class II | Z-1153-2021 | Device Design | There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration. |
| Feb 1, 2021 | Class II | Z-1154-2021 | Device Design | There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration. |
| Feb 1, 2021 | Class II | Z-1155-2021 | Device Design | There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 14 of the 80 ancestors have a recall of any class.
- Of its descendants, K231126 (E Surgical, LLC, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120791.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
This device is intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. This device is intended to be used with a standard electrosurgical generator with footswitch control and a standard return electrode connection, and the electrode is to be activated only when immersed in a conductive media such as standard saline solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161558: Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161558
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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