510(k) · Cleared
ClearedArthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control, Power Cord and Wands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 1, 2006 as substantially equivalent to K033257 (Arthrocare Corp., 2003) after a 7-day review. Its family tree reaches back 10 generations to 1994. 40 later devices descend from it.
- Decided
- Dec 1, 2006
- Review
- 7 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K936109 (1994). 55 ancestors in all, the oldest K800617 (1980). 40 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations between
- 3 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 2 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 1 generation backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- This deviceK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- Descendant · cites it directly · 39 of its ownK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- Descendant · 2 generations on · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- Descendant · 3 generations on · 9 of its ownK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- Descendant · 2 generations on · 8 of its ownK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- Descendant · 3 generations on · 6 of its ownK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
Show all 10 generations
- Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 9 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 8 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 7 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 6 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 5 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 4 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 3 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 2 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 1 generation backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- This deviceK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K070374Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · cites it directly39descendants
- K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · 2 generations on18descendants
- K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013 · 3 generations on9descendants
- K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009 · 2 generations on8descendants
- K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −9 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −7 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −6 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −5 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −4 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −3 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −2 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −1 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| 0 (this device) | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| +1 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| +2 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| +3 | K133314 | Harmonic Focus Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2013 | — |
| +2 | K083415 | Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device | Peak Surgical, Inc. | 2009 | — |
| +3 | K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K033257 | Arthrocare Ent Plasma WandsSummary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArttuioCare ® ENT Plasma Wands K033257, cleared 10/30/03 Product Description The ArthroCare ENT Plasma Wands are bipolar, single use, high frequency electrosurgical de… | 2003 |
What descends from it? (40)
See all 403 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?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 55 ancestors have a recall of any class.
- Of its descendants, K070374 (Arthrocare Corp., 2007) has gone furthest, with 39 descendants of its own.
- 2 other devices also cite its predicate K033257.
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 | — |
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 (99 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
* 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/K063538 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063538: Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control, Power Cord and Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063538
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