510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Modification to Arthrocare Arthrowands

K083306510(k) SpecialCleared Dec 10, 200830-day reviewClass II21 CFR 878.4400Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 10, 2008 as substantially equivalent to K082980 (Arthrocare Corp., 2008) after a 30-day review. Its family tree reaches back 12 generations to 2001. 14 later devices descend from it. It has been recalled once.

Decided
Dec 10, 2008
Review
30 days
Class
Class II
Product code
GEI
Recalls
1
Predicates
1

Its longest line of descent runs back 12 generations to K011083 (2001). 24 ancestors in all, the oldest K000778 (2000). 14 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2002: 2 other ancestors2001: 4 other ancestors2000: 4 other ancestors2018: 2 descendants cleared2016: 4 descendants cleared2015: 1 descendant cleared2012: 1 descendant cleared2017: 1 descendant cleared2023: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK011083 · Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand · Arthrocare Corp. · 2001K013463 · Arthrocare Arthro Wands, Enetec Evac Plasma Wand · Arthrocare Corp. · 2001K020557 · Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands · Arthrocare Corp. · 2002K030551 · Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control; Power Cord; Wands · Arthrocare Corp. · 2003 · recalled×2: 2 generations cleared close together, K032504 (2003), K033584 (2003) K052686 · Arthrocare Arthrowands · Arthrocare Corp. · 2005K070958 · Modification to Arthrocare Arthrowands · Arthrocare Corp. · 2007×2: 2 generations cleared close together, K071963 (2007), K072865 (2007) ×2: 2 generations cleared close together, K082323 (2008), K082980 (2008) 200020052010201520202025
Other ancestors, by generationDescendants, by generation 5 generations back: 1 other ancestor6 generations back: 2 other ancestors7 generations back: 2 other ancestors8 generations back: 6 other ancestors9 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K082980 · Arthrocare Arthrowands · Arthrocare Corp. · 2008 · recalledK082323 · Arthrocare Arthrowands · Arthrocare Corp. · 2008K072865 · Modificaton to: Arthrocare Arthrowands · Arthrocare Corp. · 2007K071963 · Modification to: Arthrocare Arthrowands · Arthrocare Corp. · 2007K070958 · Modification to Arthrocare Arthrowands · Arthrocare Corp. · 2007K052686 · Arthrocare Arthrowands · Arthrocare Corp. · 2005K033584 · Arthrocare Arthrowands · Arthrocare Corp. · 2003 · recalledK032504 · Arthrocare System · Arthrocare Corp. · 2003K030551 · Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control; Power Cord; Wands · Arthrocare Corp. · 2003 · recalledK020557 · Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands · Arthrocare Corp. · 2002K013463 · Arthrocare Arthro Wands, Enetec Evac Plasma Wand · Arthrocare Corp. · 2001K011083 · Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand · Arthrocare Corp. · 2001−10−50+5
  1. Root · 12 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
  2. 8 generations between
  3. 3 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
  4. 2 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
  5. 1 generation backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
  6. This deviceK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008
  7. Descendant · cites it directly · 4 of its ownK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
  8. Descendant · cites it directly · 4 of its ownK120791 Ambient Turboflash 90 IfsArthocare Corporation · 2012
  9. Descendant · 2 generations on · 3 of its ownK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
  10. Descendant · cites it directly · 3 of its ownK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
  11. Descendant · 3 generations on · 2 of its ownK183346 FLOW 90 WandArthroCare Corporation · 2019
Show all 12 generations
  1. Root · 12 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
  2. 11 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
  3. 10 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
  4. 9 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
  5. 8 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
  6. 7 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
  7. 6 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
  8. 5 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
  9. 4 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
  10. 3 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
  11. 2 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
  12. 1 generation backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
  13. This deviceK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2012: 12015: 12016: 42017: 12018: 22019: 12023: 12024: 12025: 12026: 1
2012high 4 (2016) · low 0 (2013)2026

Most influential descendants

Showing 5 of 14 · See all
  • K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015 · cites it directly4descendants
  • K120791Ambient Turboflash 90 IfsArthocare Corporation · 2012 · cites it directly4descendants
  • K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016 · 2 generations on3descendants
  • K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · cites it directly3descendants
  • K183346FLOW 90 WandArthroCare Corporation · 2019 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K011083Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare…Arthrocare Corp.2001—
−11K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp.2001—
−10K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.2002—
−9K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot…Arthrocare Corp.20031
−8K032504Arthrocare SystemArthrocare Corp.2003—
−7K033584Arthrocare ArthrowandsArthrocare Corp.20031
−6K052686Arthrocare ArthrowandsArthrocare Corp.2005—
−5K070958Modification to Arthrocare ArthrowandsArthrocare Corp.2007—
−4K071963Modification to: Arthrocare ArthrowandsArthrocare Corp.2007—
−3K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp.2007—
−2K082323Arthrocare ArthrowandsArthrocare Corp.2008—
−1K082980Arthrocare ArthrowandsArthrocare Corp.200812
0 (this device)K083306Modification to Arthrocare ArthrowandsArthrocare Corp.2008—
+1K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation2015—
+1K120791Ambient Turboflash 90 IfsArthocare Corporation2012—
+2K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation2016—
+1K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation20162
+3K183346FLOW 90 WandArthroCare Corporation2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200040
200140
200220
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201510
201640
201710
201820
201910
202310
202410
202510
202610
FIG. 1 — Lineage of K083306, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K082980Arthrocare Arthrowands
Summary page 1
…l Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare ArthroWands® K082980 Product Description The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for spe…
Arthrocare Corp.200812

Also cleared against K082980: 2 other devices →

What descends from it? (14)

See all 14

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation20154
K120791Ambient Turboflash 90 IfsArthocare Corporation20124
K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation20163
K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation20162
K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger SwitchesArthroCare Corporation20180
K173741Reprocessed ArthoCare Ablation WandRenovo, Inc.20180
K171324Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew DyonicsSurgical Instrument Service and Savings, Inc.20170
K162126Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated…ArthroCare Corporation20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 27, 2014Class IIZ-0579-2015Package design/selectionPotential breach of sterile barrier due to defective product tray.

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.
  • 3 of the 24 ancestors have a recall of any class.
  • Of its descendants, K143235 (ArthroCare Corporation, 2015) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K082980.

How does its category compare?

All GEI devices

GEI 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

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

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 Shoulder Synovectomy…

Read the full statement (165 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.

Also cleared against K082980

2 other devices cite the same predicate.

  • K173741Reprocessed ArthoCare Ablation WandRenovo, Inc. · 2018
  • K090393Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model 72202139,72202141…Arthrocare Corp. · 2009

More from Arthrocare Corp.

112 FDA decisions under this applicant name. See the company

  • K153186Adjustable Fixation DeviceArthrocare Corp. · 2016
  • K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp. · 2013
  • K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp Tipped Obturator…Arthrocare Corp. · 2013
  • K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low Profile Drill Guide…Arthrocare Corp. · 2011
  • K111397Titan TI Suture Anchor SystemArthrocare Corp. · 2011

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The GEI category page

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https://510kreport.com/device/K083306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083306: 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/K083306

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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