510(k) · Cleared
Recalled · Class II · 2015EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroCare Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 19, 2014 as substantially equivalent to K070374 (Arthrocare Corp., 2007) after a 33-day review. Its family tree reaches back 12 generations to 1994. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 19, 2014
- Review
- 33 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 12 generations to K936109 (1994). 57 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations between
- 3 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 2 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 1 generation backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- This deviceK142999 EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma…ArthroCare Corporation · 2014
- Descendant · cites it directly · 2 of its ownK202006 ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set…ArthroCare Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK253680 LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK230914 ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF…ArthroCare Corporation · 2023
- Descendant · cites it directly · 0 of its ownK172647 Reprocessed ArthroCare ENT CoblatorRenovo, Inc. · 2018
Show all 12 generations
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 11 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 10 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 9 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 8 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 7 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 6 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 5 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 4 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 3 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 2 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 1 generation backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- This deviceK142999 EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma…ArthroCare Corporation · 2014
Most influential descendants
Showing 4 of 4 · See all- K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation · 2020 · cites it directly2descendants
- K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation · 2026 · 2 generations on0descendants
- K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation · 2023 · 2 generations on0descendants
- K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −11 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −9 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −8 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −7 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −6 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −5 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −3 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −2 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −1 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| 0 (this device) | K142999 | EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with… | ArthroCare Corporation | 2014 | — |
| +1 | K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT… | ArthroCare Corporation | 2020 | — |
| +2 | K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | 2026 | — |
| +2 | K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION… | ArthroCare Corporation | 2023 | — |
| +1 | K172647 | Reprocessed ArthroCare ENT Coblator | Renovo, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K070374 | Arthrocare Ent Plasma WandSummary page 5…uct Code: GEI CFR Section: 21 CFR 878.4400 Predicate Device ENT Plasma Wands EVac 70 Xtra Wand with Integrated Cable K070374 (April 25, 2007) PROcise XP Wand with Integrated Cable K070374 (April 25, 2007) Description The Art… | 2007 |
| † | K033257 | Arthrocare Ent Plasma Wands | 2003 |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Jun 2, 2015 | Class II | Z-2105-2015 | Nonconforming Material/Component | Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications. |
| May 15, 2015 | Class II | Z-1832-2015 | Component design/selection | Potential component failure causing device inoperability |
| May 15, 2015 | Class II | Z-1833-2015 | Component design/selection | Potential component failure resulting in inoperability |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 57 ancestors have a recall of any class.
- Of its descendants, K202006 (ArthroCare Corporation, 2020) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K070374.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ArthroCare ENT Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: • Adenoidectomy • Cysts • Head, Neck, Oral, and Sinus Surgery • Mastoidectomy • Myringotomy with Effective Hemorrhage Control • Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates • Nasopharyngeal/Laryngeal Indications including Tracheal Procedures…
Read the full statement (102 words)
The ArthroCare ENT Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
• Adenoidectomy
• Cysts
• Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• Myringotomy with Effective Hemorrhage Control
• Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal/Laryngeal Indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
• Neck Mass
• Papilloma Keloids
• Submucosal Palatal Shrinkage
• Submucosal Tissue Shrinkage
• Tonsillectomy (including palatine tonsils)
• Traditional Uvulopalatoplasty (RAUP)
• Tumors
• Tissue in the Uvula/Soft Palate for the Treatment Of Snoring
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142999 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142999: EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142999
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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