The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand.
| Device ID | K210423 |
| 510k Number | K210423 |
| Device Name: | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Arthrocare Corporation 7000 West William Cannon Drive Building One Austin, TX 78735 |
| Contact | Shruthi Bhat |
| Correspondent | Shruthi Bhat Arthrocare Corporation 7000 West William Cannon Drive Building One Austin, TX 78735 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-11 |
| Decision Date | 2021-06-24 |