510(k) · Cleared
ClearedWerewolf RF20000 Controller, FLOW 50 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 Aug 22, 2016 as substantially equivalent to K143235 (ArthroCare Corporation, 2015) after a 26-day review. Its family tree reaches back 14 generations to 2001. 3 later devices descend from it.
- Decided
- Aug 22, 2016
- Review
- 26 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K011083 (2001). 28 ancestors in all, the oldest K000778 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 10 generations between
- 3 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 2 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
- This deviceK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
- Descendant · cites it directly · 2 of its ownK183346 FLOW 90 WandArthroCare Corporation · 2019
- Descendant · 2 generations on · 1 of its ownK240964 FLOW 90? WandArthroCare Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK254122 FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026
Show all 14 generations
- Root · 14 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 13 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 12 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 11 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 10 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 9 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 8 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 7 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 6 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 5 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 4 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 3 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 2 generations backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
- This deviceK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −13 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −12 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −11 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −10 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −9 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −8 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −7 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −6 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −5 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −4 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −3 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| −2 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| −1 | K143235 | RF20000a Controller, FLOW 50 Wand | ArthroCare Corporation | 2015 | — |
| 0 (this device) | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | ArthroCare Corporation | 2016 | — |
| +1 | K183346 | FLOW 90 Wand | ArthroCare Corporation | 2019 | — |
| +2 | K240964 | FLOW 90? Wand | ArthroCare Corporation | 2024 | — |
| +3 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K143235 | RF20000a Controller, FLOW 50 WandSummary page 5…l cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Regulation Number: 21 CFR 878.4400 Predicate Devices RF20000a Coblation System (K143235) Description Werewolf Coblation System(RF20000) The RF20000 Coblation System is an electrosurgical system consisting of a bipo… | 2015 |
| † | K082666 | Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183346 | FLOW 90 Wand | 2019 | 2 |
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.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K183346 (ArthroCare Corporation, 2019) has gone furthest, with 2 descendants 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. 2016, 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 Werewolf Coblation System, comprised of the FLOW 50 Wand and the RF20000 Controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: Ablation/Debridement All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) Articular Cartilage Bursectomy Chondroplasty Fascia Ligament Scar Tissue Soft Tissue Tendon Excision/Resection Labrum Cysts…
Read the full statement (103 words)
The Werewolf Coblation System, comprised of the FLOW 50 Wand and the RF20000 Controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:
Ablation/Debridement
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)
Articular Cartilage
Bursectomy
Chondroplasty
Fascia
Ligament
Scar Tissue
Soft Tissue
Tendon
Excision/Resection
Labrum
Cysts
Ligament
Loose Bodies
Plica Removal
Scar Tissue
Soft Tissue
Synovial Membrane
Tendon
Hip
Acetabular Labrum
Capsular Release
Cartilage Flaps
Knee
ACL/PCL
Notchplasty
Meniscal Cystectomy
Discoid Meniscus
Lateral Release
Meniscectomy
Villusectomy
Shoulder
Acromioplasty
Subacromial Decompression
Frozen Shoulder Release
Glenoid Labrum
Wrist
Triangular Fibrocartilage (TFCC)
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/K162074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162074: Werewolf RF20000 Controller, FLOW 50 Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162074
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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