510(k) · Cleared
ClearedArthrocare System 15000 Controller, 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 Dec 4, 2009 as substantially equivalent to K090393 (Arthrocare Corp., 2009) after a 59-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Dec 4, 2009
- Review
- 59 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K011083 (2001). 27 ancestors in all, the oldest K000778 (2000). No later device cites it as a predicate yet.
- Root · 13 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 9 generations between
- 3 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 2 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK090393 Arthrocare System 15000 Contoller, Model 72202149, Arthrocare…Arthrocare Corp. · 2009
- This deviceK093165 Arthrocare System 15000 Controller, ArthrowandsArthrocare Corp. · 2009
Show all 13 generations
- Root · 13 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 12 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 11 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 10 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 9 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 8 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 7 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 6 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 5 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 4 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 3 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 2 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK090393 Arthrocare System 15000 Contoller, Model 72202149, Arthrocare…Arthrocare Corp. · 2009
- This deviceK093165 Arthrocare System 15000 Controller, ArthrowandsArthrocare Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −12 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −11 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −10 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −9 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −8 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −7 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −6 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −5 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −4 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −3 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −2 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| −1 | K090393 | Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands… | Arthrocare Corp. | 2009 | — |
| 0 (this device) | K093165 | Arthrocare System 15000 Controller, Arthrowands | Arthrocare Corp. | 2009 | — |
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 |
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K090393 | Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model…Summary page 1…Cutting and Coagulation Device and Accessories (21 CER 878.4400) Predicate Devices ArthroCare System 15000 K090393 Product Description The ArthroCare System 15000 consists of a bipolar, high frequency, electrosurgical generator called the Con… | 2009 |
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 8 years and passes through 1 company; a new generation was cleared every 5 months on median.
- 3 of the 27 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 System 15000 is 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); Acroniomioplast (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); Subacronmial…
Read the full statement (166 words)
The ArthroCare System 15000 is 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); Acroniomioplast (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); Subacronmial Decompression (Shoulder); Synovectomy (All Joints); Tendon (All Joints).
Excision and Resection: Acetabular Labrumn (Hip); Articular Labrumn (All Joints); Capsule (All Joints); Capsular Release (Knee); Cartilage Flaps (Knee); Cysts (All Joints); Discoid Meniscus (Knee); Frozen Shoulder Release (Shoulder); Olenoidale Labrumn (Shoulder); Lateral Release (Knee); Ligament (All Joints); Loose Bodies (All Joints); Meniscal Cystectomy (Knee); Meniscectorn (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); Rtator Cuff (Shoulder); Teno (All Joints); Wrist Tendons (Wrist).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093165: Arthrocare System 15000 Controller, Arthrowands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093165
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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