The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Evac 70 Xtra Plasma Wand With Integrated Cable, Procise Xp Plasma Wand With Integrated Cable.
| Device ID | K142999 |
| 510k Number | K142999 |
| Device Name: | EVac 70 Xtra Plasma Wand With Integrated Cable, PROcise XP Plasma Wand With Integrated Cable |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ArthroCare Corporation 7000 West William Cannon Drive Austin, TX 78735 |
| Contact | Ashley M. Johnston |
| Correspondent | Ashley M. Johnston ArthroCare Corporation 7000 West 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 | 2014-10-17 |
| Decision Date | 2014-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470009743 | K142999 | 000 |
| 00817470003710 | K142999 | 000 |
| 00817470003727 | K142999 | 000 |