510(k) Report

510(k) · Cleared

Cleared

Arthrocare Arthro Wands, Enetec Evac Plasma Wand

K013463510(k) SpecialCleared Nov 15, 200128-day reviewClass II21 CFR 878.4400

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 Nov 15, 2001 as substantially equivalent to K011083 (Arthrocare Corp., 2001) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 2001. 134 later devices descend from it.

Decided
Nov 15, 2001
Review
28 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K011083 (2001). 2 ancestors in all. 134 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2002: 3 descendants cleared2004: 4 descendants cleared2010: 4 descendants cleared2018: 6 descendants cleared2005: 3 descendants cleared2003: 4 descendants cleared2012: 11 descendants cleared2007: 5 descendants cleared2017: 7 descendants cleared2016: 14 descendants cleared2008: 12 descendants cleared2022: 4 descendants cleared2013: 8 descendants cleared2009: 4 descendants cleared2014: 7 descendants cleared2011: 6 descendants cleared2006: 2 descendants cleared2025: 3 descendants cleared2015: 9 descendants cleared2023: 7 descendants cleared2024: 2 descendants cleared2021: 2 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2026: 2 descendants clearedK011083 · Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand · Arthrocare Corp. · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 12 descendants3 generations forward: 23 descendants4 generations forward: 22 descendants5 generations forward: 11 descendants6 generations forward: 15 descendants7 generations forward: 20 descendants8 generations forward: 7 descendants9 generations forward: 8 descendants10 generations forward: 2 descendants11 generations forward: 1 descendant12 generations forward: 2 descendants13 generations forward: 4 descendants14 generations forward: 2 descendants15 generations forward: 1 descendant K011083 · Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand · Arthrocare Corp. · 20010+5+10+15
  1. Root · 1 generation backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
  2. This deviceK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
  3. Descendant · cites it directly · 76 of its ownK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
  4. Descendant · cites it directly · 55 of its ownK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
  5. Descendant · 2 generations on · 52 of its ownK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
  6. Descendant · 3 generations on · 51 of its ownK032504 Arthrocare SystemArthrocare Corp. · 2003
  7. Descendant · 2 generations on · 50 of its ownK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004

Showing 5 of 134 descendants. See all descendants

Descendants cleared per year

2002: 32003: 42004: 42005: 32006: 22007: 52008: 122009: 42010: 42011: 62012: 112013: 82014: 72015: 92016: 142017: 72018: 62019: 22020: 32021: 22022: 42023: 72024: 22025: 32026: 2
2002high 14 (2016) · low 2 (2006)2026

Most influential descendants

Showing 5 of 134 · See all
  • K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC · 2002 · cites it directly76descendants
  • K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp. · 2002 · cites it directly55descendants
  • K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control…Arthrocare Corp. · 2003 · 2 generations on52descendants
  • K032504Arthrocare SystemArthrocare Corp. · 2003 · 3 generations on51descendants
  • K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004 · 2 generations on50descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011083Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare…Arthrocare Corp.2001—
0 (this device)K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp.2001—
+1K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC2002—
+1K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.2002—
+2K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot…Arthrocare Corp.20031
+3K032504Arthrocare SystemArthrocare Corp.2003—
+2K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200340
200440
200530
200620
200750
2008120
200940
201040
201160
2012110
201380
201470
201590
2016140
201770
201860
201920
202030
202120
202240
202370
202420
202530
202620
FIG. 1 — Lineage of K013463, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K011083Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare Arthrowand
Summary page 1
…ctrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) ArthroCare ArthroWands® ENTec® EVac™ Plasma Wand™ Electrosurgical Device and Accessories K011083 KO011279 e The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of bl…
Arthrocare Corp.2001—
*K011279Entec Evac Plasma Wand
Summary page 3
…ntial Equivalence This Special 510(k) proposes a modification in performance specifications and materials for the Wands, which were previously cleared under K011083 and K011279 on June 28, 2001 and July 19, 2001, respectively. The indications for use, technology, principle of operation, dimensional specif…
Arthrocare Corp.2001—

Also cleared against K011083: 5 other devices →

What descends from it? (134)

See all 134

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

NumberDeviceApplicantDecidedDescendants
K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276
K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.200255
K041810Serfas Energy SystemStryker Endoscopy200417
K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss20100

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K021777 (Gyrus Ent LLC, 2002) has gone furthest, with 76 descendants of its own.
  • 5 other devices also cite its predicate K011083.

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.

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?

ArthroCare ArthroWands 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…

Read the full statement (191 words)

ArthroCare ArthroWands

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

ENTec EVac Plasma Wand

The ENTec EVac Plasma Wand is indicated for ablation, coagulation, and hemostasis of soft tissue in tonsillectomy and adenoidectomy procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K011083

5 other devices cite the same predicate.

  • K173741Reprocessed ArthoCare Ablation WandRenovo, Inc. · 2018
  • K101711Ceruleau Electrosurgical ProbeNuortho Surgical, Inc. · 2010
  • K053567Athrocare Topaz ArthrowandsArthrocare Corp. · 20061 recall
  • K041810Serfas Energy SystemStryker Endoscopy · 20043 recalls
  • K031371Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003

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

Recent decisions in GEI

The GEI category page

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  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K013463 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013463: Arthrocare Arthro Wands, Enetec Evac Plasma Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013463

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026