510(k) Report

510(k) · Cleared

Cleared

Paragon T2 Wand with Integrated Cable

K153675510(k) SpecialCleared Jan 15, 201625-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 Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jan 15, 2016 as substantially equivalent to K033584 (Arthrocare Corp., 2003) after a 25-day review. Its family tree reaches back 6 generations to 2001.

Decided
Jan 15, 2016
Review
25 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K011083 (2001). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestorK011083 · 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 · recalledK032504 · Arthrocare System · Arthrocare Corp. · 2003K033584 · Arthrocare Arthrowands · Arthrocare Corp. · 2003 · recalled2000200520102015
Other ancestors, by generation 6 generations back: 1 other ancestor K033584 · 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. · 2001−50
  1. Root · 6 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
  2. 5 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
  3. 4 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
  4. 3 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
  5. 2 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
  6. 1 generation backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
  7. This deviceK153675 Paragon T2 Wand with Integrated CableArthroCare Corporation · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K011083Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare…Arthrocare Corp.2001—
−5K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp.2001—
−4K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.2002—
−3K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot…Arthrocare Corp.20031
−2K032504Arthrocare SystemArthrocare Corp.2003—
−1K033584Arthrocare ArthrowandsArthrocare Corp.20031
0 (this device)K153675Paragon T2 Wand with Integrated CableArthroCare Corporation2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K153675, 2001–2016Source: 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K033584Arthrocare Arthrowands
Summary page 6
…ode: GEI CFR Section: 21 CFR 878.4400 Predicate Device ArthroCare ArthroWands (Paragon T2 Wand with Integrated Cable) K033584 (November 28, 2003) Description The ArthroCare…
Arthrocare Corp.20031

Also cleared against K033584: 4 other devices →

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 15 years and passes through 2 companies; a new generation was cleared every 5 months on median.
  • 2 of the 7 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K033584.

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. 2016, 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 —…

Read the full statement (208 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 K033584

4 other devices cite the same predicate.

  • K173741Reprocessed ArthoCare Ablation WandRenovo, Inc. · 2018
  • K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
  • K052686Arthrocare ArthrowandsArthrocare Corp. · 2005
  • K041810Serfas Energy SystemStryker Endoscopy · 20043 recalls

More from ArthroCare Corporation

37 FDA decisions under this applicant name. See the company

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  • K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation · 2026
  • K240964FLOW 90? WandArthroCare Corporation · 2024
  • K232290INTELLIO SHIFT SystemArthroCare Corporation · 2023
  • K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+…ArthroCare Corporation · 2023

Recent decisions in GEI

The GEI category page

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https://510kreport.com/device/K153675 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153675: Paragon T2 Wand with Integrated Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153675

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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