# K210423: Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand

- Pathway: 510(k) (Traditional)
- Applicant: ArthroCare Corporation
- Decided: Jun 24, 2021 after 133 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: 4 generations back to K954171 (1996). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052859: Aquamantys Pump Generator System, Tissuelink Medical, Inc. (2005) Summary page 5.

## Most influential descendants
- K232290: INTELLIO SHIFT System (2023), 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 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.

Source page: https://510kreport.com/device/K210423
Methodology: https://510kreport.com/methodology