The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Werewolf Rf20000 Controller, Flow 50 Wand.
| Device ID | K162074 |
| 510k Number | K162074 |
| Device Name: | Werewolf RF20000 Controller, FLOW 50 Wand |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORPORATION 7000 W. WILLIAM CANNON DRIVE Austin, TX 78735 |
| Contact | Shirley Hyink |
| Correspondent | Shirley Hyink ARTHROCARE CORPORATION 7000 W. WILLIAM CANNON DRIVE Austin, TX 78735 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-27 |
| Decision Date | 2016-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556645352 | K162074 | 000 |
| 00885556632710 | K162074 | 000 |
| 00885556632635 | K162074 | 000 |
| 00885556632628 | K162074 | 000 |
| 00885556624890 | K162074 | 000 |
| 00885556692516 | K162074 | 000 |