The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Werewolf Coblation System, Coblation Halo Wand.
| Device ID | K192027 |
| 510k Number | K192027 |
| Device Name: | WEREWOLF COBLATION System, COBLATION HALO Wand |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Arthrocare Corporation 7000 West William Cannon Drive Austin, TX 78735 |
| Contact | Shruthi Bhat |
| Correspondent | Shruthi Bhat Arthrocare Corporation 7000 West William Cannon Drive 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 | 2019-07-29 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556699928 | K192027 | 000 |
| 00885556739624 | K192027 | 000 |
| 00885556776506 | K192027 | 000 |
| 00885556775592 | K192027 | 000 |