510(k) · Cleared
ClearedARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)
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 Jun 26, 2023 as substantially equivalent to K122652 (ArthroCare Corporation, 2013) and 3 other predicates after an 87-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Jun 26, 2023
- Review
- 87 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K936109 (1994). 69 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 10 generations between
- 3 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 2 generations backK122652 Arthrocare Turbinator WandArthroCare Corporation · 2013
- 1 generation backK202006 ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set…ArthroCare Corporation · 2020
- This deviceK230914 ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF…ArthroCare Corporation · 2023
Show all 14 generations
- Root · 14 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 13 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 12 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 11 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 10 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 9 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 8 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 7 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 6 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 5 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 4 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 3 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 2 generations backK122652 Arthrocare Turbinator WandArthroCare Corporation · 2013
- 1 generation backK202006 ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set…ArthroCare Corporation · 2020
- This deviceK230914 ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF…ArthroCare Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −13 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −12 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −11 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −10 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −9 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −8 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −7 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −6 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −5 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −4 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −3 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −2 | K122652 | Arthrocare Turbinator Wand | ArthroCare Corporation | 2013 | — |
| −1 | K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT… | ArthroCare Corporation | 2020 | — |
| 0 (this device) | K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION… | ArthroCare Corporation | 2023 | — |
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 | 9 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (4)
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 |
|---|---|---|---|
| * | K122652 | Arthrocare Turbinator WandSummary page 5…CFR 878.4400 Page 1 of 17 3 PREDICATE DEVICE (s) ArthroCare Turbinator Wand (K122652) compatible with WEREWOLF COBLATION System (K202006)… | 2013 |
| * | K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…Summary page 5…== Page 5 === 3 PREDICATE DEVICE (s) ArthroCare Turbinator Wand (K122652) compatible with WEREWOLF COBLATION System (K202006) WEREWOLF COBLATION SYSTEM - K210423 WEREWOLF + COB… | 2020 |
| * | K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis WandSummary page 5…nd (K122652) compatible with WEREWOLF COBLATION System (K202006) WEREWOLF COBLATION SYSTEM - K210423 WEREWOLF + COBLATION SYSTEM- K192027 REFERENCE DEVICE: FLOW 900 Wand… | 2021 |
| * | K192027 | WEREWOLF COBLATION System, COBLATION HALO WandSummary page 5…COBLATION System (K202006) WEREWOLF COBLATION SYSTEM - K210423 WEREWOLF + COBLATION SYSTEM- K192027 REFERENCE DEVICE: FLOW 900 Wand - K183346 4 DEVICE DESCRIPTION The purpose of this submissio… | 2019 |
| † | K183346 | FLOW 90 Wand | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 69 ancestors have a recall of any class.
- 1 other device also cites its predicate K122652.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 ARIS Wand, used with the WEREWOLF COBLATION System, is Indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue shrinkage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230914: ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230914
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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