The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Ambient Hipvac 50 Wand With Integrated Finger Switches, Rf20000 Coblation System, Werewolf Coblation System, Werewolf+ Coblation System.
| Device ID | K220563 |
| 510k Number | K220563 |
| Device Name: | Ambient HipVac 50 Wand With Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Arthrocare Corporation 7000 West William Cannon Drive Building One Austin, TX 78735 |
| Contact | Alexander Brankner |
| Correspondent | Alexander Brankner 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 | 2022-02-28 |
| Decision Date | 2022-09-01 |