510(k) · Cleared
ClearedWerewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis 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 Jun 24, 2021 as substantially equivalent to K052859 (Tissuelink Medical, Inc., 2005) after a 133-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.
- Decided
- Jun 24, 2021
- Review
- 133 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954171 (1996). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
- 3 generations backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
- 2 generations backK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
- 1 generation backK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
- This deviceK210423 Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal…ArthroCare Corporation · 2021
- Descendant · cites it directly · 0 of its ownK232290 INTELLIO SHIFT SystemArthroCare Corporation · 2023
- Descendant · cites it directly · 0 of its ownK230914 ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF…ArthroCare Corporation · 2023
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 |
|---|---|---|---|---|---|
| −4 | K954171 | Arco-MBC, Arco MC | Holl Meditronics, Inc. | 1996 | — |
| −3 | K993265 | Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 | Soring GmbH Medizintechnik | 1999 | — |
| −2 | K024059 | MBC Series | Soring GmbH Medizintechnik | 2003 | — |
| −1 | K052859 | Aquamantys Pump Generator System | Tissuelink Medical, Inc. | 2005 | 1 |
| 0 (this device) | K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0… | ArthroCare Corporation | 2021 | — |
| +1 | K232290 | INTELLIO SHIFT System | ArthroCare Corporation | 2023 | — |
| +1 | K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION… | ArthroCare Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K052859 | Aquamantys Pump Generator SystemSummary page 5…ion 21 CFR 878.4400 7.3 PREDICATE DEVICE(S) Aquamantys Pump Generator System and Aquamantys 6.0 Bipolar Sealer – K052859 Page 1 of 13 K210423… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K232290 (ArthroCare Corporation, 2023) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K052859.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic, orthopedic and otorhinolaryngology (ENT) procedures: Ablation/Debridement All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) • Articular Cartilage • Bursectomy • Chondroplasty • Fascia • Ligament • Scar Tissue • Soft Tissue • Synovectomy • Tendon Hip Knee • ACL/PCL •…
Read the full statement (271 words)
The WEREWOLF™ + COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic, orthopedic and otorhinolaryngology (ENT) procedures:
Ablation/Debridement
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)
• Articular Cartilage
• Bursectomy
• Chondroplasty
• Fascia
• Ligament
• Scar Tissue
• Soft Tissue
• Synovectomy
• Tendon
Hip
Knee
• ACL/PCL
• Notchplasty
• Capsular Release
• Cartilage Flaps
• Discoid Meniscus
• Lateral Release
• Meniscal Cystectomy
• Meniscectomy
• Villusectomy
Shoulder
• Acromioplasty
• Subacromial Decompression
• Frozen Shoulder Release
• Glenoid Labrum
Wrist
• Triangular Fibrocartilage (TFCC)
Excision/Resection
• Articular Labrum
• Capsule
• Cysts
• Ligament
• Loose Bodies
• Acetabular Labrum
• Plica Removal
• Scar Tissue
• Soft Tissue
• Synovial Membrane
• Tendon
ENT Resection/Ablation/Coagulation
• Tonsillectomy (including Palatine Tonsils)
• Adenoidectomy
• Uvulopalatopharyngoplasty (UPPP)
• Traditional Uvulopalatoplasty Control (RAUP)
• Nasal Airway Obstruction
• Submucosal Palatal Shrinkage
• Submucosal Tissue Shrinkage
• Nasal Airway Obstruction by reduction of Hypertrophic Nasal Turbinates
• Reduction of Turbinates for the treatment of Nasal Airway Obstruction
• Nasopharyngeal/Laryngeal indications including Tracheal Procedures
• Mastoidectomy
• Myringotomy with Effective Hemorrhage
• Papilloma
• Keloids
• Nasopharyngeal/Laryngeal Procedures
• Polypectomy
• Laryngeal Polypectomy
• Laryngeal Lesion Debulking
• Cysts
• Tumors
• Neck Mass
• Head, Neck, Oral, and Sinus Surgery
• Tissue in the Uvula/Soft Palate for the treatment of Snoring
Orthopedic Hemostasis (via coagulation) of soft tissue and bone.
The FASTSEAL 6.0 Wand, used with the WEREWOLF™+ COBLATION System, is indicated for hemostasis (via coagulation) of soft tissue and bone in orthopedic procedures.
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/K210423 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210423: Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210423
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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