The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Arthrocare Turbinator Wand.
| Device ID | K122652 |
| 510k Number | K122652 |
| Device Name: | ARTHROCARE TURBINATOR WAND |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ARTHROCARE CORPORATION 7000 W William Cannon Dr Austin, TX 78735 |
| Contact | Cheryl Frederick |
| Correspondent | Cheryl Frederick ARTHROCARE CORPORATION 7000 W William Cannon Dr 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 | 2012-08-31 |
| Decision Date | 2013-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817470008993 | K122652 | 000 |
| 00817470005240 | K122652 | 000 |
| 00817470000382 | K122652 | 000 |