510(k) · Cleared
ClearedFLOW FLEXTEND Wand (72290039)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroCare Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 30, 2026 as substantially equivalent to K240964 (ArthroCare Corporation, 2024) after a 101-day review. Its family tree reaches back 17 generations to 2001.
- Decided
- Mar 30, 2026
- Review
- 101 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K011083 (2001). 31 ancestors in all, the oldest K000778 (2000). No later device cites it as a predicate yet.
- Root · 17 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 13 generations between
- 3 generations backK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
- 2 generations backK183346 FLOW 90 WandArthroCare Corporation · 2019
- 1 generation backK240964 FLOW 90? WandArthroCare Corporation · 2024
- This deviceK254122 FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026
Show all 17 generations
- Root · 17 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 16 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 15 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 14 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 13 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 12 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 11 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 10 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 9 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 8 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 7 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 6 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 5 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 4 generations backK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
- 3 generations backK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
- 2 generations backK183346 FLOW 90 WandArthroCare Corporation · 2019
- 1 generation backK240964 FLOW 90? WandArthroCare Corporation · 2024
- This deviceK254122 FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −16 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −15 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −14 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −13 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −12 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −11 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −10 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −9 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −8 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −7 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −6 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| −5 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| −4 | K143235 | RF20000a Controller, FLOW 50 Wand | ArthroCare Corporation | 2015 | — |
| −3 | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | ArthroCare Corporation | 2016 | — |
| −2 | K183346 | FLOW 90 Wand | ArthroCare Corporation | 2019 | — |
| −1 | K240964 | FLOW 90? Wand | ArthroCare Corporation | 2024 | — |
| 0 (this device) | K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | 2026 | — |
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 |
|---|---|---|---|
| * | K240964 | FLOW 90? WandSummary page 6…Page 1 of 8 K254122 35.3 PREDICATE DEVICE(S) FLOW 90◇ Wand cleared under K240964. REFERENCE DEVICE(S) SIDEWINDER Wand cleared under K162074. This predicate has not been subject to a design-related recall. EF… | 2024 |
| † | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | 2016 |
| † | K003893 | Vulcan Ablator Electrosurgical Probes, Vulcan Ligament Chisel Electrosurgical Probes… | 2001 |
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 25 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 4 of the 31 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. 2026, 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 FLOW FLEXTEND Wand, used with a 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/Debridement: Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Scar Tissue, Soft Tissue, Synovectomy, Tendon. Excision/Resection: Articular Labrum, Capsule…
Read the full statement (105 words)
The FLOW FLEXTEND Wand, used with a 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/Debridement: 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/Debridement: ACL/PCL, Notchplasty.
Excision/Resection: Capsular release, Cartilage Flaps, Discoid Meniscus, Lateral release, Meniscal Cystectomy, Meniscectomy, Villusectomy.
Shoulder
Ablation/Debridement: 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.
https://510kreport.com/device/K254122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254122: FLOW FLEXTEND Wand (72290039).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254122
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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