510(k) Report

510(k) · Cleared

Cleared

FLOW 90? Wand

K240964510(k) SpecialCleared May 8, 202429-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 May 8, 2024 as substantially equivalent to K183346 (ArthroCare Corporation, 2019) after a 29-day review. Its family tree reaches back 16 generations to 2001. 1 later device descends from it.

Decided
May 8, 2024
Review
29 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 16 generations to K011083 (2001). 30 ancestors in all, the oldest K000778 (2000). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2007: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2002: 2 other ancestors2001: 4 other ancestors2000: 4 other ancestors2026: 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) ×3: 3 generations cleared close together, K082323 (2008), K082980 (2008), K083306 (2008) K143235 · RF20000a Controller, FLOW 50 Wand · ArthroCare Corporation · 2015K162074 · Werewolf RF20000 Controller, FLOW 50 Wand · ArthroCare Corporation · 2016K183346 · FLOW 90 Wand · ArthroCare Corporation · 2019200020052010201520202025
Other ancestors, by generationDescendants, by generation 4 generations back: 1 other ancestor5 generations back: 1 other ancestor9 generations back: 1 other ancestor10 generations back: 3 other ancestors11 generations back: 2 other ancestors12 generations back: 6 other ancestors 1 generation forward: 1 descendant K183346 · FLOW 90 Wand · ArthroCare Corporation · 2019K162074 · Werewolf RF20000 Controller, FLOW 50 Wand · ArthroCare Corporation · 2016K143235 · RF20000a Controller, FLOW 50 Wand · ArthroCare Corporation · 2015K083306 · Modification to Arthrocare Arthrowands · Arthrocare Corp. · 2008 · recalledK082980 · 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. · 2001−15−10−50
  1. Root · 16 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
  2. 12 generations between
  3. 3 generations backK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
  4. 2 generations backK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
  5. 1 generation backK183346 FLOW 90 WandArthroCare Corporation · 2019
  6. This deviceK240964 FLOW 90? WandArthroCare Corporation · 2024
  7. Descendant · cites it directly · 0 of its ownK254122 FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026
Show all 16 generations
  1. Root · 16 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
  2. 15 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
  3. 14 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
  4. 13 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
  5. 12 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
  6. 11 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
  7. 10 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
  8. 9 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
  9. 8 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
  10. 7 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
  11. 6 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
  12. 5 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
  13. 4 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
  14. 3 generations backK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
  15. 2 generations backK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
  16. 1 generation backK183346 FLOW 90 WandArthroCare Corporation · 2019
  17. This deviceK240964 FLOW 90? WandArthroCare Corporation · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K011083Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare…Arthrocare Corp.2001—
−15K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp.2001—
−14K020557Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsArthrocare Corp.2002—
−13K030551Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot…Arthrocare Corp.20031
−12K032504Arthrocare SystemArthrocare Corp.2003—
−11K033584Arthrocare ArthrowandsArthrocare Corp.20031
−10K052686Arthrocare ArthrowandsArthrocare Corp.2005—
−9K070958Modification to Arthrocare ArthrowandsArthrocare Corp.2007—
−8K071963Modification to: Arthrocare ArthrowandsArthrocare Corp.2007—
−7K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp.2007—
−6K082323Arthrocare ArthrowandsArthrocare Corp.2008—
−5K082980Arthrocare ArthrowandsArthrocare Corp.200812
−4K083306Modification to Arthrocare ArthrowandsArthrocare Corp.20081
−3K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation2015—
−2K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation2016—
−1K183346FLOW 90 WandArthroCare Corporation2019—
0 (this device)K240964FLOW 90? WandArthroCare Corporation2024—
+1K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200040
200140
200220
200310
200410
200710
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K240964, 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? (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
*K183346FLOW 90 Wand
Summary page 6
…Page 1 of 6 K240964 PREDICATE DEVICE(S) FLOW 90◊ Wand cleared under K183346. SUBJECT DEVICE DESCRIPTION The FLOW 90 Wand is a bipolar, RF electrosurgical device designed for resection, ablation, and coag…
ArthroCare Corporation2019—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation20260

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 23 years and passes through 2 companies; a new generation was cleared every 10 months on median.
  • 4 of the 30 ancestors have a recall of any class.
  • Of its descendants, K254122 (ArthroCare Corporation, 2026) has gone furthest, with 0 descendants of its own.

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. 2024, 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 FLOW 90 Wand, used with Qualified Controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) - Ablation/ Debrideement - (Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Scar, Tissue, Soft Tissue, Synovectomy, Tendon) - Excision/Resection (Articular Labrum, Capsule…

Read the full statement (122 words)

The FLOW 90 Wand, used with Qualified Controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:

All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)

- Ablation/ Debrideement - (Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament,

Scar, Tissue, Soft Tissue, Synovectomy, Tendon)

- Excision/Resection (Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal,

Scar Tissue, Soft Tissue, Synovial Membrane, Tendon)

Hip

- Excision/Resection - (Acetabular Labrum)

Knee

- Ablation/ Debrideement - (ACL/PCL, Notchplasty)

- Excision/Resection - (Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release,

Meniscal Cystectomy, Meniscectomy, Villusectomy)

Shoulder

- Ablation/ Debrideement - (Subacromial Decompression)

- Excision/Resection - (Frozen Shoulder Release, Glenoid Labrum)

Wrist

- Excision/Resection - (Triangular Fibrocartilage)

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

More from ArthroCare Corporation

37 FDA decisions under this applicant name. See the company

  • K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026
  • K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation · 2026
  • K232290INTELLIO SHIFT SystemArthroCare Corporation · 2023
  • K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+…ArthroCare Corporation · 2023
  • K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System…ArthroCare Corporation · 2022

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https://510kreport.com/device/K240964 · printed Nov 4, 2026

Cite this page

510(k) Report. “K240964: FLOW 90? Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240964

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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