510(k) · Cleared
ClearedWEREWOLF COBLATION System, COBLATION HALO 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 Dec 20, 2019 as substantially equivalent to K030108 (Arthrocare Corp., 2003) and 1 other predicate after a 144-day review. Its family tree reaches back 12 generations to 1994. 3 later devices descend from it.
- Decided
- Dec 20, 2019
- Review
- 144 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K936109 (1994). 57 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations between
- 3 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 2 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 1 generation backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- This deviceK192027 WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation · 2019
- Descendant · cites it directly · 1 of its ownK251996 ENTire IRE SystemEntire Medical, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK261202 ENTire IRE SystemEntire Medical, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK230914 ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF…ArthroCare Corporation · 2023
Show all 12 generations
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 11 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 10 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 9 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 8 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 7 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 6 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 5 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 4 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 3 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 2 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 1 generation backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- This deviceK192027 WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation · 2019
Most influential descendants
Showing 3 of 3 · See all- K251996ENTire IRE SystemEntire Medical, Ltd. · 2026 · cites it directly1descendant
- K261202ENTire IRE SystemEntire Medical, Ltd. · 2026 · 2 generations on0descendants
- K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −11 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −9 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −8 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −7 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −6 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −5 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −3 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −2 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −1 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| 0 (this device) | K192027 | WEREWOLF COBLATION System, COBLATION HALO Wand | ArthroCare Corporation | 2019 | — |
| +1 | K251996 | ENTire IRE System | Entire Medical, Ltd. | 2026 | — |
| +2 | K261202 | ENTire IRE System | Entire Medical, Ltd. | 2026 | — |
| +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 |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K030108 | Arthrocare Ent Coblator Surgery SystemSummary page 6…CFR Section 21 CFR 878.4400 7.3 PREDICATE DEVICE(S) ARTHROCARE ENT COBLATOR II SURGERY SYSTEM cleared via K030108 PROCISE XP Wand cleared via K070374 7.4 DESCRIPTION 7.4.1 WEREWOLF™ (RF20000) COBLATIO… | 2003 |
| * | K070374 | Arthrocare Ent Plasma WandSummary page 6…ARTHROCARE ENT COBLATOR II SURGERY SYSTEM cleared via K030108 PROCISE XP Wand cleared via K070374 7.4 DESCRIPTION 7.4.1 WEREWOLF™ (RF20000) COBLATION™ System The proposed WEREWOLF COBLATION System consists of:… | 2007 |
| † | K143235 | RF20000a Controller, FLOW 50 Wand | 2015 |
| † | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | 2016 |
What descends from it? (3)
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 6 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 57 ancestors have a recall of any class.
- Of its descendants, K251996 (Entire Medical, Ltd., 2026) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K030108.
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 WEREWOLF COBLATION System controller is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following otorhinolaryngology (ENT) procedures: Resection/Ablation/Coagulation - Tonsillectomy (Including Palatine Tonsils) - Adenoidectomy - Uvulopalatopharyngoplasty (UPPP) - Traditional Uvulopalatoplasty (RAUP) - Nasal Airway Obstruction - Submucosal Palatal Shrinkage - Submucosal Tissue Shrinkage -…
Read the full statement (181 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 otorhinolaryngology (ENT) procedures:
Resection/Ablation/Coagulation
- Tonsillectomy (Including Palatine Tonsils)
- Adenoidectomy
- Uvulopalatopharyngoplasty (UPPP)
- Traditional Uvulopalatoplasty (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 Control
- 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
The COBLATION HALO Wand, used with the WEREWOLF COBLATION System, is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: tonsillectomy, adenoidectomy, and uvulopalatopharyngoplasty (UPPP). It is intended for procedures using a conductive media, such as normal saline or Ringer’s lactate.
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/K192027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192027: WEREWOLF COBLATION System, COBLATION HALO Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192027
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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