# K230914: ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)

- Pathway: 510(k) (Traditional)
- Applicant: ArthroCare Corporation
- Decided: Jun 26, 2023 after 87 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: 14 generations back to K936109 (1994). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122652: Arthrocare Turbinator Wand, ArthroCare Corporation (2013) Summary page 5.
- K202006: ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System, ArthroCare Corporation (2020) Summary page 5.
- K210423: Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand, ArthroCare Corporation (2021) Summary page 5.
- K192027: WEREWOLF COBLATION System, COBLATION HALO Wand, ArthroCare Corporation (2019) Summary page 5.

## Indications for use
The ARIS 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: nasal airway obstruction by reduction of hypertrophic nasal turbinates and submucosal tissue shrinkage.

Source page: https://510kreport.com/device/K230914
Methodology: https://510kreport.com/methodology