510(k) · Cleared
Recalled · Class II · 2021Bovie Disposable Bipolar Ablator
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 Jan 15, 2016 as substantially equivalent to K120791 (Arthocare Corporation, 2012) and 5 other predicates after a 112-day review. Its family tree reaches back 14 generations to 2001. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 15, 2016
- Review
- 112 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 14 generations to K011083 (2001). 79 ancestors in all, the oldest K852143 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 10 generations between
- 3 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 2 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK120791 Ambient Turboflash 90 IfsArthocare Corporation · 2012
- This deviceK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016
- Descendant · cites it directly · 2 of its ownK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016 · Recalled
- 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 14 generations
- Root · 14 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 13 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 12 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 11 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 10 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 9 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 8 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 7 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 6 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 5 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 4 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 3 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 2 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK120791 Ambient Turboflash 90 IfsArthocare Corporation · 2012
- This deviceK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016
Most influential descendants
Showing 3 of 3 · See all- K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation · 2016 · cites it directly2descendants
- K231126Eblator DeviceE Surgical, LLC · 2023 · cites it directly1descendant
- K251899E BlatorNew Deantronics Taiwan, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −13 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −12 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −11 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −10 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −9 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −8 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −7 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −6 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −5 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −4 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −3 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| −2 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| −1 | K120791 | Ambient Turboflash 90 Ifs | Arthocare Corporation | 2012 | — |
| 0 (this device) | K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016 | — |
| +1 | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating… | Bovie Medical Corporation | 2016 | 3 |
| +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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (6)
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 4…olar Ablator 50°, Non-Aspirating Classification: 21CFR 878.4400; Class II; Product Code GEI Legally Marketed Predicate Device(s): • K120791, K083306 ArthroCare SuperTurbo Vac 90, TurboVac 90, Super MultiVac 50, and Arthrowand Devices • K992406 DePuy Syn… | 2012 |
| * | K083306 | Modification to Arthrocare ArthrowandsSummary page 4…tor 50°, Non-Aspirating Classification: 21CFR 878.4400; Class II; Product Code GEI Legally Marketed Predicate Device(s): • K120791, K083306 ArthroCare SuperTurbo Vac 90, TurboVac 90, Super MultiVac 50, and Arthrowand Devices • K992406 DePuy Synthes VAPR… | 2008 |
| * | K992406 | Vapr 2.3MM End Effect Electrode for Use with Vapr SystemSummary page 4…I Legally Marketed Predicate Device(s): • K120791, K083306 ArthroCare SuperTurbo Vac 90, TurboVac 90, Super MultiVac 50, and Arthrowand Devices • K992406 DePuy Synthes VAPR Suction Electrodes, 2.3mm • K113545, K100638 DePuy Synthes CoolPulse 90 Electrode • K122425 DePu… | 1999 |
| * | K113545 | Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System…Summary page 4…3306 ArthroCare SuperTurbo Vac 90, TurboVac 90, Super MultiVac 50, and Arthrowand Devices • K992406 DePuy Synthes VAPR Suction Electrodes, 2.3mm • K113545, K100638 DePuy Synthes CoolPulse 90 Electrode • K122425 DePuy Synthes VAPR P50 Electrode… | 2012 |
| * | K100638 | Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Summary page 4…roCare SuperTurbo Vac 90, TurboVac 90, Super MultiVac 50, and Arthrowand Devices • K992406 DePuy Synthes VAPR Suction Electrodes, 2.3mm • K113545, K100638 DePuy Synthes CoolPulse 90 Electrode • K122425 DePuy Synthes VAPR P50 Electrode… | 2010 |
| * | K122425 | Vapr P50 Suction Electrode Vapr S90 Suction Electrode Vapr P50 Suction Electrode with…Summary page 4…50, and Arthrowand Devices • K992406 DePuy Synthes VAPR Suction Electrodes, 2.3mm • K113545, K100638 DePuy Synthes CoolPulse 90 Electrode • K122425 DePuy Synthes VAPR P50 Electrode 5-1… | 2012 |
What descends from it? (3)
2 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)
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-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.
- 13 of the 79 ancestors have a recall of any class.
- Of its descendants, K161558 (Bovie Medical Corporation, 2016) has gone furthest, with 2 descendants 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/K152777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152777: Bovie Disposable Bipolar Ablator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152777
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