510(k) · Cleared
Recalled · 2011Arthrocare Arthrowands
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 Nov 5, 2008 as substantially equivalent to K082323 (Arthrocare Corp., 2008) after a 30-day review. Its family tree reaches back 11 generations to 2001. 17 later devices descend from it. It has been recalled 12 times.
- Decided
- Nov 5, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 12
- Predicates
- 1
Its longest line of descent runs back 11 generations to K011083 (2001). 23 ancestors in all, the oldest K000778 (2000). 17 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 7 generations between
- 3 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 2 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 1 generation backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- This deviceK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008
- Descendant · cites it directly · 14 of its ownK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- Descendant · 2 generations on · 4 of its ownK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
- Descendant · 2 generations on · 4 of its ownK120791 Ambient Turboflash 90 IfsArthocare Corporation · 2012
- Descendant · 3 generations on · 3 of its ownK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
- Descendant · 2 generations on · 3 of its ownK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
Show all 11 generations
- Root · 11 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 10 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 9 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 8 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 7 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 6 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 5 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 4 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 3 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 2 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 1 generation backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- This deviceK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K083306Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · cites it directly14descendants
- K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015 · 2 generations on4descendants
- K120791Ambient Turboflash 90 IfsArthocare Corporation · 2012 · 2 generations on4descendants
- K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016 · 3 generations on3descendants
- K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −10 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −9 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −8 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −7 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −6 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −5 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −4 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −3 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −2 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −1 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| 0 (this device) | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| +1 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| +2 | K143235 | RF20000a Controller, FLOW 50 Wand | ArthroCare Corporation | 2015 | — |
| +2 | K120791 | Ambient Turboflash 90 Ifs | Arthocare Corporation | 2012 | — |
| +3 | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | ArthroCare Corporation | 2016 | — |
| +2 | K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K082323 | Arthrocare ArthrowandsSummary page 1…l Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare AitfiroWands® K082323 ProWWdctDecrioton T7rhe ArthroCare AfthrdWands are bipolar, single use, high frequency electrosurgical devices designed for spe… | 2008 |
What descends from it? (17)
See all 173 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 |
|---|---|---|---|---|
| Aug 8, 2011 | Not classified | Z-0621-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0618-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0619-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0620-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0615-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0616-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0617-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0622-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0623-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0624-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0625-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
| Aug 8, 2011 | Not classified | Z-0626-2012 | Reprocessing Controls | Product is being removed from the field due to an over-label issue. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 5 months on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K083306 (Arthrocare Corp., 2008) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K082323.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: Ablation and Debridement ACL/PCL — Knee Acromioplasty — Shoulder Articular Cartilage — All Joints Bursectomy — All Joints Chondroplasty — All Joints Facia — All Joints Ligament — All Joints Notchplasty — Knee Scar Tissue — All Joints Soft Tissue — All Joints Subacromial Decompression —…
Read the full statement (208 words)
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
Ablation and Debridement
ACL/PCL — Knee
Acromioplasty — Shoulder
Articular Cartilage — All Joints
Bursectomy — All Joints
Chondroplasty — All Joints
Facia — All Joints
Ligament — All Joints
Notchplasty — Knee
Scar Tissue — All Joints
Soft Tissue — All Joints
Subacromial Decompression — Shoulder
Synovectomy — All Joints
Tendon — All Joints
Excision and Resection
Acetabular Labrum — Hip
Articular Labrum — All Joints
Capsule — All Joints
Capsular Release — Knee
Cartilage Flaps — Knee
Cysts — All Joints
Discoid Meniscus — Knee
Frozen Shoulder Release — Shoulder
Glenoidale Labrum — Shoulder
Lateral Release — Knee
Ligament — All Joints
Loose Bodies — All Joints
Meniscal Cystectomy — Knee
Meniscectomy — Knee
Plica Removal — All Joints
Scar Tissue — All Joints
Soft Tissue — All Joints
Synovial Membrane — All Joints
Tendon — All Joints
Triangular Fibrocartilage (TFCC) — Wrist
Villusectomy — Knee
Coagulation
ACL/PCL — Knee
Articular Cartilage — All Joints
Carpal Ligaments — Wrist
Glenohumeral Capsule — Shoulder
Ligament — All Joints
Medial Retinaculum — Knee
Rotator Cuff — Shoulder
Tendon — All Joints
Wrist Tendons — Wrist
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082980 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082980: Arthrocare Arthrowands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082980
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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