510(k) · Cleared
ClearedModification to: Arthrocare 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 Aug 7, 2007 as substantially equivalent to K070958 (Arthrocare Corp., 2007) and 1 other predicate after a 22-day review. Its family tree reaches back 8 generations to 2001. 21 later devices descend from it.
- Decided
- Aug 7, 2007
- Review
- 22 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K011083 (2001). 20 ancestors in all, the oldest K000778 (2000). 21 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 7 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 6 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 5 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 4 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 3 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 2 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 1 generation backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- This deviceK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- Descendant · cites it directly · 20 of its ownK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- Descendant · 2 generations on · 19 of its ownK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- Descendant · 3 generations on · 17 of its ownK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- Descendant · 4 generations on · 14 of its ownK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- Descendant · 5 generations on · 4 of its ownK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · cites it directly20descendants
- K082323Arthrocare ArthrowandsArthrocare Corp. · 2008 · 2 generations on19descendants
- K082980Arthrocare ArthrowandsArthrocare Corp. · 2008 · 3 generations on17descendants
- K083306Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · 4 generations on14descendants
- K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −7 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −6 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −5 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −4 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −3 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −2 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −1 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| 0 (this device) | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| +1 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| +2 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| +3 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| +4 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| +5 | K143235 | RF20000a Controller, FLOW 50 Wand | ArthroCare Corporation | 2015 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K070958 | Modification to Arthrocare ArthrowandsSummary page 1…l Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare ® ArthroWands® K070958 ArthroCare System K040338 Product Description The ArthroCare ArthroWands are bipolar, single use, high f… | 2007 |
| * | K040338 | Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02…Summary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare ® ArthroWands® K070958 ArthroCare System K040338 Product Description The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for spec… | 2004 |
What descends from it? (21)
See all 212 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 6 years and passes through 1 company; a new generation was cleared every 5 months on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K072865 (Arthrocare Corp., 2007) has gone furthest, with 20 descendants of its own.
- 2 other devices also cite its predicate K070958.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 -…
Read the full statement (251 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/K071963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071963: Modification to: Arthrocare Arthrowands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071963
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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