510(k) · Cleared
ClearedFLOW 90 Wand
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 Jan 24, 2019 as substantially equivalent to K162074 (ArthroCare Corporation, 2016) after a 52-day review. Its family tree reaches back 15 generations to 2001. 2 later devices descend from it.
- Decided
- Jan 24, 2019
- Review
- 52 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K011083 (2001). 29 ancestors in all, the oldest K000778 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 11 generations between
- 3 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 2 generations backK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
- 1 generation backK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
- This deviceK183346 FLOW 90 WandArthroCare Corporation · 2019
- Descendant · cites it directly · 1 of its ownK240964 FLOW 90? WandArthroCare Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK254122 FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026
Show all 15 generations
- Root · 15 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 14 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 13 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 12 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 11 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 10 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 9 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 8 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 7 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 6 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 5 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 4 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 3 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 2 generations backK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
- 1 generation backK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
- This deviceK183346 FLOW 90 WandArthroCare Corporation · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −14 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −13 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −12 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −11 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −10 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −9 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −8 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −7 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −6 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −5 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −4 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| −3 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| −2 | K143235 | RF20000a Controller, FLOW 50 Wand | ArthroCare Corporation | 2015 | — |
| −1 | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | ArthroCare Corporation | 2016 | — |
| 0 (this device) | K183346 | FLOW 90 Wand | ArthroCare Corporation | 2019 | — |
| +1 | K240964 | FLOW 90? Wand | ArthroCare Corporation | 2024 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K162074 | Werewolf RF20000 Controller, FLOW 50 WandSummary page 5…s: Class II Product Code: GEI CFR Section: 21 CFR 878.4400 3. Predicate Device FLOW™ 50 Wand cleared under K162074. Page 1 of 5… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240964 | FLOW 90? Wand | 2024 | 1 |
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 18 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K240964 (ArthroCare Corporation, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 90 Wand, used with the WEREWOLF COBLATION System, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: Joint Ablation/Debridement Excision/Resection All Joints x Articular Cartilage x Articular Labrum (Hip, x Bursectomy x Capsule Knee, x Chondroplasty x Cysts Shoulder, x Fascia x Ligament Wrist, x Ligament x Loose Bodies Ankle, x Scar…
Read the full statement (136 words)
The FLOW 90 Wand, used with the WEREWOLF COBLATION System, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:
Joint Ablation/Debridement Excision/Resection
All Joints x Articular Cartilage x Articular Labrum
(Hip, x Bursectomy x Capsule
Knee, x Chondroplasty x Cysts
Shoulder, x Fascia x Ligament
Wrist, x Ligament x Loose Bodies
Ankle, x Scar Tissue x Plica Removal
Elbow) x Soft Tissue x Scar Tissue
x Synovectomy x Soft Tissue
x Tendon x Synovial Membrane
x Tendon
Hip x Acetabular Labrum
Knee x ACL/PCL x Capsular Release
x Notchplasty x Cartilage Flaps
x Discoid Meniscus
x Lateral Release
x Meniscal Cystectomy
x Meniscectomy
x Villusectomy
Shoulder x Acromioplasty x Frozen Shoulder Release
x Subacromial x Glenoid Labrum
Decompression
Wrist x Triangular Fibrocartilage
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183346: FLOW 90 Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183346
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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