# K192027: WEREWOLF COBLATION System, COBLATION HALO Wand

- Pathway: 510(k) (Traditional)
- Applicant: ArthroCare Corporation
- Decided: Dec 20, 2019 after 144 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K936109 (1994). 57 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030108: Arthrocare Ent Coblator Surgery System, Arthrocare Corp. (2003) Summary page 6.
- K070374: Arthrocare Ent Plasma Wand, Arthrocare Corp. (2007) Summary page 6.

## Most influential descendants
- K251996: ENTire IRE System (2026), 1 descendant of its own
- K261202: ENTire IRE System (2026), 0 descendants of its own
- K230914: ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K192027
Methodology: https://510kreport.com/methodology