510(k) · Cleared
ClearedArthrocare Controller, Authrocare Cable, Foot Control, Power Cord, 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 Jun 6, 2002 as substantially equivalent to K020557 (Arthrocare Corp., 2002) after a 27-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Jun 6, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011083 (2001). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 2 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 1 generation backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- This deviceK021519 Arthrocare Controller, Authrocare Cable, Foot Control, Power Cord…Arthrocare Corp. · 2002
- Descendant · cites it directly · 0 of its ownK032223 Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic…Cook Vascular, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K032223Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent…Cook Vascular, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −2 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −1 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| 0 (this device) | K021519 | Arthrocare Controller, Authrocare Cable, Foot Control, Power Cord, Wands | Arthrocare Corp. | 2002 | — |
| +1 | K032223 | Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic… | Cook Vascular, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032223 | Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent… | 2003 | 0 |
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 1 year and passes through 1 company; a new generation was cleared every 4 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K032223 (Cook Vascular, Inc., 2003) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K020557.
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 ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: Ablation and Debridement ACWPCL — Knee Acromioplasty — Shoulder Articular Cartilage — All Joints Bursectomv — All Joints Chondroplastv — All Joints Facia — All Joints Ligament — All Joints ScarTissue — All Joints SoftTissue — All Joints Subacromial Decompression — Shoulder Synovectomy…
Read the full statement (197 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
ACWPCL — Knee
Acromioplasty — Shoulder
Articular Cartilage — All Joints
Bursectomv — All Joints
Chondroplastv — All Joints
Facia — All Joints
Ligament — All Joints
ScarTissue — All Joints
SoftTissue — All Joints
Subacromial Decompression — Shoulder
Synovectomy — All Joints
Tendon — All Joints
Excision and Resection
Acetabular Labnun — Hip
ArticularLabrum — All Joints
Capsule — All Joints
Capsular Release — Knee
CartilageFlaps — Knee
cysts — All Joints
Discoid Meniscus — Knee
Frozen Shoulder Release — Shoulder
Glenoidale Labrum — Shoulder
LateralRelease — Knee
Ligament — Ali Joints
LooseBodies — All Joints
Menisd Cystectomy — Knee
Meniscectomy — Knee
Arthroscopic and Orth'opedic Procedures
Plica Removal
ScarTissue — All Joints
SoftTissue — All Joints
Synovial Membrane — All Joints
Tendon — AH Joints
Triangular Fibrocartilage (TFCC) — Wrist
Villusectomv — Knee
Coagulation
ACL/PCL — Knee
Articular Cartilane — All Joints
Carpal Ligaments — Wrist
Glenohumeral Capsule — Shoulder
Ligament — All Joints
Medial Retinaculum — Knee
potatorcuff — Shoulder
Tendon — All Joints
Wrist Tendons — Wrist
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021519 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021519: Arthrocare Controller, Authrocare Cable, Foot Control, Power Cord, Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021519
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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