The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Ent Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf Ent Adapter, Werewolf Coblation System.
| Device ID | K202006 |
| 510k Number | K202006 |
| Device Name: | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ArthroCare Corporation 7000 West William Cannon Drive, Building One Austin, TX 78749 |
| Contact | Jean Asquith |
| Correspondent | Jean Asquith ArthroCare Corporation 7000 West William Cannon Drive, Building One Austin, TX 78749 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-21 |
| Decision Date | 2020-12-18 |